Breast cancer drugs: FDA approval, development time, efficacy, clinical benefits, innovation, trials, endpoints, quality of life, value, and price
Objective This study analyzes the development, benefits, trial evidence, and price of new breast cancer drugs with US Food and Drug Administration (FDA) approval. Methods We identified 26 drugs with 42 FDA-approved indications for early and metastatic breast cancer (2000–2023). Data were collected f...
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Gespeichert in:
| Autor*in: |
Michaeli, Julia Caroline [verfasserIn] Michaeli, Thomas [verfasserIn] Trapani, Dario [verfasserIn] Albers, Sebastian [verfasserIn] Dannehl, Dominik [verfasserIn] Würstlein, Rachel [verfasserIn] Michaeli, Daniel Tobias [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2024 |
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| Schlagwörter: |
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| Anmerkung: |
© The Author(s) 2024 |
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| Übergeordnetes Werk: |
Enthalten in: Breast cancer - Springer Nature Singapore, 1994, 31(2024), 6 vom: 25. Sept., Seite 1144-1155 |
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| Übergeordnetes Werk: |
volume:31 ; year:2024 ; number:6 ; day:25 ; month:09 ; pages:1144-1155 |
| Links: |
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| DOI / URN: |
10.1007/s12282-024-01634-x |
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| Katalog-ID: |
SPR057883157 |
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| 100 | 1 | |a Michaeli, Julia Caroline |e verfasserin |0 (orcid)0000-0001-6484-7161 |4 aut | |
| 245 | 1 | 0 | |a Breast cancer drugs: FDA approval, development time, efficacy, clinical benefits, innovation, trials, endpoints, quality of life, value, and price |
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| 520 | |a Objective This study analyzes the development, benefits, trial evidence, and price of new breast cancer drugs with US Food and Drug Administration (FDA) approval. Methods We identified 26 drugs with 42 FDA-approved indications for early and metastatic breast cancer (2000–2023). Data were collected from FDA labels, clinicaltrials.gov, and Medicare and Medicaid. Overall survival (OS) and progression-free survival (PFS) hazard ratios (HRs) and tumor response’s relative risk (RR) alongside objective response rate (ORR) were meta-analyzed. Results The median development time for breast cancer drugs was 7.8 years (95% CI 6.2–10.8). 26% of treatments were considered innovative (“first-in-indication”) with 88% acting via a targeted mechanism. 64% were small molecules, 19% antibodies, and 18% antibody-drug conjugates. 38% were approved for HR + and 31% for HER2 + breast cancer. 6 indications were for early and 36 for metastatic breast cancer. Indications utilized FDA’s special programs: orphan (2%), fast track (24%), accelerated approval (19%), priority review (74%), breakthrough therapy (44%). Approval was predominantly supported by phase 3 trials (88%) of randomized controlled design (66%), enrolling a median of 585 patients (IQR 417–752) at 181 centers (IQR 142–223) across 19 countries (IQR 17–20). New drugs’ HR were 0.78 for OS (95% CI 0.74–0.82) and 0.59 for PFS (95% CI 0.54–0.64) with a RR for tumor response of 1.61 (95% CI 1.46–1.76). Median improvements of OS were 2.8 months (IQR 1.8–5.8) and PFS were 4.4 months (IQR 2.2–7.1). In single-arm trials, the average ORR was 31% (95% CI 10–53). In meta-regressions, the correlation between OS/PFS was 0.34 (p = 0.031) and OS/response was 0.01 (p = 0.435). 60% of treatments had a ‘high-value’ ESMO-MCBS score with 14% demonstrating improvements in quality of life. The median price was $16,013 per month (95% CI 13,097–17,617). There was no association between prices and patient benefit. The median value per life year gained was $62,419 (IQR 25,840–86,062). Conclusions Over the past two decades, the development of innovative and effective drugs transformed the treatment landscape for breast cancer patients. Yet, investigators and regulators must safeguard that highly-priced new drugs demonstrate improvements in patient-centered clinical endpoints: overall survival and quality of life. | ||
| 650 | 4 | |a Breast cancer |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Early breast cancer |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Cancer drugs |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Clinical trials |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Antibody-drug conjugates |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a FDA approval |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Value-based pricing |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Innovation |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Biomarker |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Antibody |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a HER2 |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Hormone receptor |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a BRCA |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Quality of life |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Overall survival |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Progression-free survival |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Tumor response |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Objective response rate |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a ESMO-MCBS |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Metastatic breast cancer |7 (dpeaa)DE-He213 | |
| 700 | 1 | |a Michaeli, Thomas |e verfasserin |0 (orcid)0000-0003-0293-9401 |4 aut | |
| 700 | 1 | |a Trapani, Dario |e verfasserin |0 (orcid)0000-0003-1672-9560 |4 aut | |
| 700 | 1 | |a Albers, Sebastian |e verfasserin |0 (orcid)0000-0002-6688-764X |4 aut | |
| 700 | 1 | |a Dannehl, Dominik |e verfasserin |0 (orcid)0000-0002-7653-8283 |4 aut | |
| 700 | 1 | |a Würstlein, Rachel |e verfasserin |4 aut | |
| 700 | 1 | |a Michaeli, Daniel Tobias |e verfasserin |0 (orcid)0000-0003-2913-1867 |4 aut | |
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10.1007/s12282-024-01634-x doi (DE-627)SPR057883157 (SPR)s12282-024-01634-x-e DE-627 ger DE-627 rakwb eng 610 VZ 44.92 bkl Michaeli, Julia Caroline verfasserin (orcid)0000-0001-6484-7161 aut Breast cancer drugs: FDA approval, development time, efficacy, clinical benefits, innovation, trials, endpoints, quality of life, value, and price 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Objective This study analyzes the development, benefits, trial evidence, and price of new breast cancer drugs with US Food and Drug Administration (FDA) approval. Methods We identified 26 drugs with 42 FDA-approved indications for early and metastatic breast cancer (2000–2023). Data were collected from FDA labels, clinicaltrials.gov, and Medicare and Medicaid. Overall survival (OS) and progression-free survival (PFS) hazard ratios (HRs) and tumor response’s relative risk (RR) alongside objective response rate (ORR) were meta-analyzed. Results The median development time for breast cancer drugs was 7.8 years (95% CI 6.2–10.8). 26% of treatments were considered innovative (“first-in-indication”) with 88% acting via a targeted mechanism. 64% were small molecules, 19% antibodies, and 18% antibody-drug conjugates. 38% were approved for HR + and 31% for HER2 + breast cancer. 6 indications were for early and 36 for metastatic breast cancer. Indications utilized FDA’s special programs: orphan (2%), fast track (24%), accelerated approval (19%), priority review (74%), breakthrough therapy (44%). Approval was predominantly supported by phase 3 trials (88%) of randomized controlled design (66%), enrolling a median of 585 patients (IQR 417–752) at 181 centers (IQR 142–223) across 19 countries (IQR 17–20). New drugs’ HR were 0.78 for OS (95% CI 0.74–0.82) and 0.59 for PFS (95% CI 0.54–0.64) with a RR for tumor response of 1.61 (95% CI 1.46–1.76). Median improvements of OS were 2.8 months (IQR 1.8–5.8) and PFS were 4.4 months (IQR 2.2–7.1). In single-arm trials, the average ORR was 31% (95% CI 10–53). In meta-regressions, the correlation between OS/PFS was 0.34 (p = 0.031) and OS/response was 0.01 (p = 0.435). 60% of treatments had a ‘high-value’ ESMO-MCBS score with 14% demonstrating improvements in quality of life. The median price was $16,013 per month (95% CI 13,097–17,617). There was no association between prices and patient benefit. The median value per life year gained was $62,419 (IQR 25,840–86,062). Conclusions Over the past two decades, the development of innovative and effective drugs transformed the treatment landscape for breast cancer patients. Yet, investigators and regulators must safeguard that highly-priced new drugs demonstrate improvements in patient-centered clinical endpoints: overall survival and quality of life. Breast cancer (dpeaa)DE-He213 Early breast cancer (dpeaa)DE-He213 Cancer drugs (dpeaa)DE-He213 Clinical trials (dpeaa)DE-He213 Antibody-drug conjugates (dpeaa)DE-He213 FDA approval (dpeaa)DE-He213 Value-based pricing (dpeaa)DE-He213 Innovation (dpeaa)DE-He213 Biomarker (dpeaa)DE-He213 Antibody (dpeaa)DE-He213 HER2 (dpeaa)DE-He213 Hormone receptor (dpeaa)DE-He213 BRCA (dpeaa)DE-He213 Quality of life (dpeaa)DE-He213 Overall survival (dpeaa)DE-He213 Progression-free survival (dpeaa)DE-He213 Tumor response (dpeaa)DE-He213 Objective response rate (dpeaa)DE-He213 ESMO-MCBS (dpeaa)DE-He213 Metastatic breast cancer (dpeaa)DE-He213 Michaeli, Thomas verfasserin (orcid)0000-0003-0293-9401 aut Trapani, Dario verfasserin (orcid)0000-0003-1672-9560 aut Albers, Sebastian verfasserin (orcid)0000-0002-6688-764X aut Dannehl, Dominik verfasserin (orcid)0000-0002-7653-8283 aut Würstlein, Rachel verfasserin aut Michaeli, Daniel Tobias verfasserin (orcid)0000-0003-2913-1867 aut Enthalten in Breast cancer Springer Nature Singapore, 1994 31(2024), 6 vom: 25. Sept., Seite 1144-1155 (DE-627)548636184 (DE-600)2394259-9 1880-4233 nnns volume:31 year:2024 number:6 day:25 month:09 pages:1144-1155 https://dx.doi.org/10.1007/s12282-024-01634-x X:SPRINGER Resolving-System kostenfrei Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_72 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_2574 GBV_ILN_4029 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4116 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4155 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4315 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.92 VZ AR 31 2024 6 25 09 1144-1155 |
| spelling |
10.1007/s12282-024-01634-x doi (DE-627)SPR057883157 (SPR)s12282-024-01634-x-e DE-627 ger DE-627 rakwb eng 610 VZ 44.92 bkl Michaeli, Julia Caroline verfasserin (orcid)0000-0001-6484-7161 aut Breast cancer drugs: FDA approval, development time, efficacy, clinical benefits, innovation, trials, endpoints, quality of life, value, and price 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Objective This study analyzes the development, benefits, trial evidence, and price of new breast cancer drugs with US Food and Drug Administration (FDA) approval. Methods We identified 26 drugs with 42 FDA-approved indications for early and metastatic breast cancer (2000–2023). Data were collected from FDA labels, clinicaltrials.gov, and Medicare and Medicaid. Overall survival (OS) and progression-free survival (PFS) hazard ratios (HRs) and tumor response’s relative risk (RR) alongside objective response rate (ORR) were meta-analyzed. Results The median development time for breast cancer drugs was 7.8 years (95% CI 6.2–10.8). 26% of treatments were considered innovative (“first-in-indication”) with 88% acting via a targeted mechanism. 64% were small molecules, 19% antibodies, and 18% antibody-drug conjugates. 38% were approved for HR + and 31% for HER2 + breast cancer. 6 indications were for early and 36 for metastatic breast cancer. Indications utilized FDA’s special programs: orphan (2%), fast track (24%), accelerated approval (19%), priority review (74%), breakthrough therapy (44%). Approval was predominantly supported by phase 3 trials (88%) of randomized controlled design (66%), enrolling a median of 585 patients (IQR 417–752) at 181 centers (IQR 142–223) across 19 countries (IQR 17–20). New drugs’ HR were 0.78 for OS (95% CI 0.74–0.82) and 0.59 for PFS (95% CI 0.54–0.64) with a RR for tumor response of 1.61 (95% CI 1.46–1.76). Median improvements of OS were 2.8 months (IQR 1.8–5.8) and PFS were 4.4 months (IQR 2.2–7.1). In single-arm trials, the average ORR was 31% (95% CI 10–53). In meta-regressions, the correlation between OS/PFS was 0.34 (p = 0.031) and OS/response was 0.01 (p = 0.435). 60% of treatments had a ‘high-value’ ESMO-MCBS score with 14% demonstrating improvements in quality of life. The median price was $16,013 per month (95% CI 13,097–17,617). There was no association between prices and patient benefit. The median value per life year gained was $62,419 (IQR 25,840–86,062). Conclusions Over the past two decades, the development of innovative and effective drugs transformed the treatment landscape for breast cancer patients. Yet, investigators and regulators must safeguard that highly-priced new drugs demonstrate improvements in patient-centered clinical endpoints: overall survival and quality of life. Breast cancer (dpeaa)DE-He213 Early breast cancer (dpeaa)DE-He213 Cancer drugs (dpeaa)DE-He213 Clinical trials (dpeaa)DE-He213 Antibody-drug conjugates (dpeaa)DE-He213 FDA approval (dpeaa)DE-He213 Value-based pricing (dpeaa)DE-He213 Innovation (dpeaa)DE-He213 Biomarker (dpeaa)DE-He213 Antibody (dpeaa)DE-He213 HER2 (dpeaa)DE-He213 Hormone receptor (dpeaa)DE-He213 BRCA (dpeaa)DE-He213 Quality of life (dpeaa)DE-He213 Overall survival (dpeaa)DE-He213 Progression-free survival (dpeaa)DE-He213 Tumor response (dpeaa)DE-He213 Objective response rate (dpeaa)DE-He213 ESMO-MCBS (dpeaa)DE-He213 Metastatic breast cancer (dpeaa)DE-He213 Michaeli, Thomas verfasserin (orcid)0000-0003-0293-9401 aut Trapani, Dario verfasserin (orcid)0000-0003-1672-9560 aut Albers, Sebastian verfasserin (orcid)0000-0002-6688-764X aut Dannehl, Dominik verfasserin (orcid)0000-0002-7653-8283 aut Würstlein, Rachel verfasserin aut Michaeli, Daniel Tobias verfasserin (orcid)0000-0003-2913-1867 aut Enthalten in Breast cancer Springer Nature Singapore, 1994 31(2024), 6 vom: 25. Sept., Seite 1144-1155 (DE-627)548636184 (DE-600)2394259-9 1880-4233 nnns volume:31 year:2024 number:6 day:25 month:09 pages:1144-1155 https://dx.doi.org/10.1007/s12282-024-01634-x X:SPRINGER Resolving-System kostenfrei Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_72 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_2574 GBV_ILN_4029 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4116 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4155 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4315 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.92 VZ AR 31 2024 6 25 09 1144-1155 |
| allfields_unstemmed |
10.1007/s12282-024-01634-x doi (DE-627)SPR057883157 (SPR)s12282-024-01634-x-e DE-627 ger DE-627 rakwb eng 610 VZ 44.92 bkl Michaeli, Julia Caroline verfasserin (orcid)0000-0001-6484-7161 aut Breast cancer drugs: FDA approval, development time, efficacy, clinical benefits, innovation, trials, endpoints, quality of life, value, and price 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Objective This study analyzes the development, benefits, trial evidence, and price of new breast cancer drugs with US Food and Drug Administration (FDA) approval. Methods We identified 26 drugs with 42 FDA-approved indications for early and metastatic breast cancer (2000–2023). Data were collected from FDA labels, clinicaltrials.gov, and Medicare and Medicaid. Overall survival (OS) and progression-free survival (PFS) hazard ratios (HRs) and tumor response’s relative risk (RR) alongside objective response rate (ORR) were meta-analyzed. Results The median development time for breast cancer drugs was 7.8 years (95% CI 6.2–10.8). 26% of treatments were considered innovative (“first-in-indication”) with 88% acting via a targeted mechanism. 64% were small molecules, 19% antibodies, and 18% antibody-drug conjugates. 38% were approved for HR + and 31% for HER2 + breast cancer. 6 indications were for early and 36 for metastatic breast cancer. Indications utilized FDA’s special programs: orphan (2%), fast track (24%), accelerated approval (19%), priority review (74%), breakthrough therapy (44%). Approval was predominantly supported by phase 3 trials (88%) of randomized controlled design (66%), enrolling a median of 585 patients (IQR 417–752) at 181 centers (IQR 142–223) across 19 countries (IQR 17–20). New drugs’ HR were 0.78 for OS (95% CI 0.74–0.82) and 0.59 for PFS (95% CI 0.54–0.64) with a RR for tumor response of 1.61 (95% CI 1.46–1.76). Median improvements of OS were 2.8 months (IQR 1.8–5.8) and PFS were 4.4 months (IQR 2.2–7.1). In single-arm trials, the average ORR was 31% (95% CI 10–53). In meta-regressions, the correlation between OS/PFS was 0.34 (p = 0.031) and OS/response was 0.01 (p = 0.435). 60% of treatments had a ‘high-value’ ESMO-MCBS score with 14% demonstrating improvements in quality of life. The median price was $16,013 per month (95% CI 13,097–17,617). There was no association between prices and patient benefit. The median value per life year gained was $62,419 (IQR 25,840–86,062). Conclusions Over the past two decades, the development of innovative and effective drugs transformed the treatment landscape for breast cancer patients. Yet, investigators and regulators must safeguard that highly-priced new drugs demonstrate improvements in patient-centered clinical endpoints: overall survival and quality of life. Breast cancer (dpeaa)DE-He213 Early breast cancer (dpeaa)DE-He213 Cancer drugs (dpeaa)DE-He213 Clinical trials (dpeaa)DE-He213 Antibody-drug conjugates (dpeaa)DE-He213 FDA approval (dpeaa)DE-He213 Value-based pricing (dpeaa)DE-He213 Innovation (dpeaa)DE-He213 Biomarker (dpeaa)DE-He213 Antibody (dpeaa)DE-He213 HER2 (dpeaa)DE-He213 Hormone receptor (dpeaa)DE-He213 BRCA (dpeaa)DE-He213 Quality of life (dpeaa)DE-He213 Overall survival (dpeaa)DE-He213 Progression-free survival (dpeaa)DE-He213 Tumor response (dpeaa)DE-He213 Objective response rate (dpeaa)DE-He213 ESMO-MCBS (dpeaa)DE-He213 Metastatic breast cancer (dpeaa)DE-He213 Michaeli, Thomas verfasserin (orcid)0000-0003-0293-9401 aut Trapani, Dario verfasserin (orcid)0000-0003-1672-9560 aut Albers, Sebastian verfasserin (orcid)0000-0002-6688-764X aut Dannehl, Dominik verfasserin (orcid)0000-0002-7653-8283 aut Würstlein, Rachel verfasserin aut Michaeli, Daniel Tobias verfasserin (orcid)0000-0003-2913-1867 aut Enthalten in Breast cancer Springer Nature Singapore, 1994 31(2024), 6 vom: 25. Sept., Seite 1144-1155 (DE-627)548636184 (DE-600)2394259-9 1880-4233 nnns volume:31 year:2024 number:6 day:25 month:09 pages:1144-1155 https://dx.doi.org/10.1007/s12282-024-01634-x X:SPRINGER Resolving-System kostenfrei Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_72 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_2574 GBV_ILN_4029 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4116 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4155 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4315 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.92 VZ AR 31 2024 6 25 09 1144-1155 |
| allfieldsGer |
10.1007/s12282-024-01634-x doi (DE-627)SPR057883157 (SPR)s12282-024-01634-x-e DE-627 ger DE-627 rakwb eng 610 VZ 44.92 bkl Michaeli, Julia Caroline verfasserin (orcid)0000-0001-6484-7161 aut Breast cancer drugs: FDA approval, development time, efficacy, clinical benefits, innovation, trials, endpoints, quality of life, value, and price 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Objective This study analyzes the development, benefits, trial evidence, and price of new breast cancer drugs with US Food and Drug Administration (FDA) approval. Methods We identified 26 drugs with 42 FDA-approved indications for early and metastatic breast cancer (2000–2023). Data were collected from FDA labels, clinicaltrials.gov, and Medicare and Medicaid. Overall survival (OS) and progression-free survival (PFS) hazard ratios (HRs) and tumor response’s relative risk (RR) alongside objective response rate (ORR) were meta-analyzed. Results The median development time for breast cancer drugs was 7.8 years (95% CI 6.2–10.8). 26% of treatments were considered innovative (“first-in-indication”) with 88% acting via a targeted mechanism. 64% were small molecules, 19% antibodies, and 18% antibody-drug conjugates. 38% were approved for HR + and 31% for HER2 + breast cancer. 6 indications were for early and 36 for metastatic breast cancer. Indications utilized FDA’s special programs: orphan (2%), fast track (24%), accelerated approval (19%), priority review (74%), breakthrough therapy (44%). Approval was predominantly supported by phase 3 trials (88%) of randomized controlled design (66%), enrolling a median of 585 patients (IQR 417–752) at 181 centers (IQR 142–223) across 19 countries (IQR 17–20). New drugs’ HR were 0.78 for OS (95% CI 0.74–0.82) and 0.59 for PFS (95% CI 0.54–0.64) with a RR for tumor response of 1.61 (95% CI 1.46–1.76). Median improvements of OS were 2.8 months (IQR 1.8–5.8) and PFS were 4.4 months (IQR 2.2–7.1). In single-arm trials, the average ORR was 31% (95% CI 10–53). In meta-regressions, the correlation between OS/PFS was 0.34 (p = 0.031) and OS/response was 0.01 (p = 0.435). 60% of treatments had a ‘high-value’ ESMO-MCBS score with 14% demonstrating improvements in quality of life. The median price was $16,013 per month (95% CI 13,097–17,617). There was no association between prices and patient benefit. The median value per life year gained was $62,419 (IQR 25,840–86,062). Conclusions Over the past two decades, the development of innovative and effective drugs transformed the treatment landscape for breast cancer patients. Yet, investigators and regulators must safeguard that highly-priced new drugs demonstrate improvements in patient-centered clinical endpoints: overall survival and quality of life. Breast cancer (dpeaa)DE-He213 Early breast cancer (dpeaa)DE-He213 Cancer drugs (dpeaa)DE-He213 Clinical trials (dpeaa)DE-He213 Antibody-drug conjugates (dpeaa)DE-He213 FDA approval (dpeaa)DE-He213 Value-based pricing (dpeaa)DE-He213 Innovation (dpeaa)DE-He213 Biomarker (dpeaa)DE-He213 Antibody (dpeaa)DE-He213 HER2 (dpeaa)DE-He213 Hormone receptor (dpeaa)DE-He213 BRCA (dpeaa)DE-He213 Quality of life (dpeaa)DE-He213 Overall survival (dpeaa)DE-He213 Progression-free survival (dpeaa)DE-He213 Tumor response (dpeaa)DE-He213 Objective response rate (dpeaa)DE-He213 ESMO-MCBS (dpeaa)DE-He213 Metastatic breast cancer (dpeaa)DE-He213 Michaeli, Thomas verfasserin (orcid)0000-0003-0293-9401 aut Trapani, Dario verfasserin (orcid)0000-0003-1672-9560 aut Albers, Sebastian verfasserin (orcid)0000-0002-6688-764X aut Dannehl, Dominik verfasserin (orcid)0000-0002-7653-8283 aut Würstlein, Rachel verfasserin aut Michaeli, Daniel Tobias verfasserin (orcid)0000-0003-2913-1867 aut Enthalten in Breast cancer Springer Nature Singapore, 1994 31(2024), 6 vom: 25. Sept., Seite 1144-1155 (DE-627)548636184 (DE-600)2394259-9 1880-4233 nnns volume:31 year:2024 number:6 day:25 month:09 pages:1144-1155 https://dx.doi.org/10.1007/s12282-024-01634-x X:SPRINGER Resolving-System kostenfrei Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_72 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_2574 GBV_ILN_4029 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4116 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4155 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4315 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.92 VZ AR 31 2024 6 25 09 1144-1155 |
| allfieldsSound |
10.1007/s12282-024-01634-x doi (DE-627)SPR057883157 (SPR)s12282-024-01634-x-e DE-627 ger DE-627 rakwb eng 610 VZ 44.92 bkl Michaeli, Julia Caroline verfasserin (orcid)0000-0001-6484-7161 aut Breast cancer drugs: FDA approval, development time, efficacy, clinical benefits, innovation, trials, endpoints, quality of life, value, and price 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Objective This study analyzes the development, benefits, trial evidence, and price of new breast cancer drugs with US Food and Drug Administration (FDA) approval. Methods We identified 26 drugs with 42 FDA-approved indications for early and metastatic breast cancer (2000–2023). Data were collected from FDA labels, clinicaltrials.gov, and Medicare and Medicaid. Overall survival (OS) and progression-free survival (PFS) hazard ratios (HRs) and tumor response’s relative risk (RR) alongside objective response rate (ORR) were meta-analyzed. Results The median development time for breast cancer drugs was 7.8 years (95% CI 6.2–10.8). 26% of treatments were considered innovative (“first-in-indication”) with 88% acting via a targeted mechanism. 64% were small molecules, 19% antibodies, and 18% antibody-drug conjugates. 38% were approved for HR + and 31% for HER2 + breast cancer. 6 indications were for early and 36 for metastatic breast cancer. Indications utilized FDA’s special programs: orphan (2%), fast track (24%), accelerated approval (19%), priority review (74%), breakthrough therapy (44%). Approval was predominantly supported by phase 3 trials (88%) of randomized controlled design (66%), enrolling a median of 585 patients (IQR 417–752) at 181 centers (IQR 142–223) across 19 countries (IQR 17–20). New drugs’ HR were 0.78 for OS (95% CI 0.74–0.82) and 0.59 for PFS (95% CI 0.54–0.64) with a RR for tumor response of 1.61 (95% CI 1.46–1.76). Median improvements of OS were 2.8 months (IQR 1.8–5.8) and PFS were 4.4 months (IQR 2.2–7.1). In single-arm trials, the average ORR was 31% (95% CI 10–53). In meta-regressions, the correlation between OS/PFS was 0.34 (p = 0.031) and OS/response was 0.01 (p = 0.435). 60% of treatments had a ‘high-value’ ESMO-MCBS score with 14% demonstrating improvements in quality of life. The median price was $16,013 per month (95% CI 13,097–17,617). There was no association between prices and patient benefit. The median value per life year gained was $62,419 (IQR 25,840–86,062). Conclusions Over the past two decades, the development of innovative and effective drugs transformed the treatment landscape for breast cancer patients. Yet, investigators and regulators must safeguard that highly-priced new drugs demonstrate improvements in patient-centered clinical endpoints: overall survival and quality of life. Breast cancer (dpeaa)DE-He213 Early breast cancer (dpeaa)DE-He213 Cancer drugs (dpeaa)DE-He213 Clinical trials (dpeaa)DE-He213 Antibody-drug conjugates (dpeaa)DE-He213 FDA approval (dpeaa)DE-He213 Value-based pricing (dpeaa)DE-He213 Innovation (dpeaa)DE-He213 Biomarker (dpeaa)DE-He213 Antibody (dpeaa)DE-He213 HER2 (dpeaa)DE-He213 Hormone receptor (dpeaa)DE-He213 BRCA (dpeaa)DE-He213 Quality of life (dpeaa)DE-He213 Overall survival (dpeaa)DE-He213 Progression-free survival (dpeaa)DE-He213 Tumor response (dpeaa)DE-He213 Objective response rate (dpeaa)DE-He213 ESMO-MCBS (dpeaa)DE-He213 Metastatic breast cancer (dpeaa)DE-He213 Michaeli, Thomas verfasserin (orcid)0000-0003-0293-9401 aut Trapani, Dario verfasserin (orcid)0000-0003-1672-9560 aut Albers, Sebastian verfasserin (orcid)0000-0002-6688-764X aut Dannehl, Dominik verfasserin (orcid)0000-0002-7653-8283 aut Würstlein, Rachel verfasserin aut Michaeli, Daniel Tobias verfasserin (orcid)0000-0003-2913-1867 aut Enthalten in Breast cancer Springer Nature Singapore, 1994 31(2024), 6 vom: 25. 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Enthalten in Breast cancer 31(2024), 6 vom: 25. Sept., Seite 1144-1155 volume:31 year:2024 number:6 day:25 month:09 pages:1144-1155 |
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Enthalten in Breast cancer 31(2024), 6 vom: 25. Sept., Seite 1144-1155 volume:31 year:2024 number:6 day:25 month:09 pages:1144-1155 |
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Breast cancer Early breast cancer Cancer drugs Clinical trials Antibody-drug conjugates FDA approval Value-based pricing Innovation Biomarker Antibody HER2 Hormone receptor BRCA Quality of life Overall survival Progression-free survival Tumor response Objective response rate ESMO-MCBS Metastatic breast cancer |
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Breast cancer |
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Michaeli, Julia Caroline @@aut@@ Michaeli, Thomas @@aut@@ Trapani, Dario @@aut@@ Albers, Sebastian @@aut@@ Dannehl, Dominik @@aut@@ Würstlein, Rachel @@aut@@ Michaeli, Daniel Tobias @@aut@@ |
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2024-09-25T00:00:00Z |
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SPR057883157 |
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Methods We identified 26 drugs with 42 FDA-approved indications for early and metastatic breast cancer (2000–2023). Data were collected from FDA labels, clinicaltrials.gov, and Medicare and Medicaid. Overall survival (OS) and progression-free survival (PFS) hazard ratios (HRs) and tumor response’s relative risk (RR) alongside objective response rate (ORR) were meta-analyzed. Results The median development time for breast cancer drugs was 7.8 years (95% CI 6.2–10.8). 26% of treatments were considered innovative (“first-in-indication”) with 88% acting via a targeted mechanism. 64% were small molecules, 19% antibodies, and 18% antibody-drug conjugates. 38% were approved for HR + and 31% for HER2 + breast cancer. 6 indications were for early and 36 for metastatic breast cancer. Indications utilized FDA’s special programs: orphan (2%), fast track (24%), accelerated approval (19%), priority review (74%), breakthrough therapy (44%). Approval was predominantly supported by phase 3 trials (88%) of randomized controlled design (66%), enrolling a median of 585 patients (IQR 417–752) at 181 centers (IQR 142–223) across 19 countries (IQR 17–20). New drugs’ HR were 0.78 for OS (95% CI 0.74–0.82) and 0.59 for PFS (95% CI 0.54–0.64) with a RR for tumor response of 1.61 (95% CI 1.46–1.76). Median improvements of OS were 2.8 months (IQR 1.8–5.8) and PFS were 4.4 months (IQR 2.2–7.1). In single-arm trials, the average ORR was 31% (95% CI 10–53). In meta-regressions, the correlation between OS/PFS was 0.34 (p = 0.031) and OS/response was 0.01 (p = 0.435). 60% of treatments had a ‘high-value’ ESMO-MCBS score with 14% demonstrating improvements in quality of life. The median price was $16,013 per month (95% CI 13,097–17,617). There was no association between prices and patient benefit. The median value per life year gained was $62,419 (IQR 25,840–86,062). Conclusions Over the past two decades, the development of innovative and effective drugs transformed the treatment landscape for breast cancer patients. 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Michaeli, Julia Caroline |
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Michaeli, Julia Caroline ddc 610 bkl 44.92 misc Breast cancer misc Early breast cancer misc Cancer drugs misc Clinical trials misc Antibody-drug conjugates misc FDA approval misc Value-based pricing misc Innovation misc Biomarker misc Antibody misc HER2 misc Hormone receptor misc BRCA misc Quality of life misc Overall survival misc Progression-free survival misc Tumor response misc Objective response rate misc ESMO-MCBS misc Metastatic breast cancer Breast cancer drugs: FDA approval, development time, efficacy, clinical benefits, innovation, trials, endpoints, quality of life, value, and price |
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610 VZ 44.92 bkl Breast cancer drugs: FDA approval, development time, efficacy, clinical benefits, innovation, trials, endpoints, quality of life, value, and price Breast cancer (dpeaa)DE-He213 Early breast cancer (dpeaa)DE-He213 Cancer drugs (dpeaa)DE-He213 Clinical trials (dpeaa)DE-He213 Antibody-drug conjugates (dpeaa)DE-He213 FDA approval (dpeaa)DE-He213 Value-based pricing (dpeaa)DE-He213 Innovation (dpeaa)DE-He213 Biomarker (dpeaa)DE-He213 Antibody (dpeaa)DE-He213 HER2 (dpeaa)DE-He213 Hormone receptor (dpeaa)DE-He213 BRCA (dpeaa)DE-He213 Quality of life (dpeaa)DE-He213 Overall survival (dpeaa)DE-He213 Progression-free survival (dpeaa)DE-He213 Tumor response (dpeaa)DE-He213 Objective response rate (dpeaa)DE-He213 ESMO-MCBS (dpeaa)DE-He213 Metastatic breast cancer (dpeaa)DE-He213 |
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ddc 610 bkl 44.92 misc Breast cancer misc Early breast cancer misc Cancer drugs misc Clinical trials misc Antibody-drug conjugates misc FDA approval misc Value-based pricing misc Innovation misc Biomarker misc Antibody misc HER2 misc Hormone receptor misc BRCA misc Quality of life misc Overall survival misc Progression-free survival misc Tumor response misc Objective response rate misc ESMO-MCBS misc Metastatic breast cancer |
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ddc 610 bkl 44.92 misc Breast cancer misc Early breast cancer misc Cancer drugs misc Clinical trials misc Antibody-drug conjugates misc FDA approval misc Value-based pricing misc Innovation misc Biomarker misc Antibody misc HER2 misc Hormone receptor misc BRCA misc Quality of life misc Overall survival misc Progression-free survival misc Tumor response misc Objective response rate misc ESMO-MCBS misc Metastatic breast cancer |
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ddc 610 bkl 44.92 misc Breast cancer misc Early breast cancer misc Cancer drugs misc Clinical trials misc Antibody-drug conjugates misc FDA approval misc Value-based pricing misc Innovation misc Biomarker misc Antibody misc HER2 misc Hormone receptor misc BRCA misc Quality of life misc Overall survival misc Progression-free survival misc Tumor response misc Objective response rate misc ESMO-MCBS misc Metastatic breast cancer |
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Breast cancer drugs: FDA approval, development time, efficacy, clinical benefits, innovation, trials, endpoints, quality of life, value, and price |
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Breast cancer drugs: FDA approval, development time, efficacy, clinical benefits, innovation, trials, endpoints, quality of life, value, and price |
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Michaeli, Julia Caroline |
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Breast cancer |
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Michaeli, Julia Caroline Michaeli, Thomas Trapani, Dario Albers, Sebastian Dannehl, Dominik Würstlein, Rachel Michaeli, Daniel Tobias |
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Michaeli, Julia Caroline |
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10.1007/s12282-024-01634-x |
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(ORCID)0000-0001-6484-7161 (ORCID)0000-0003-0293-9401 (ORCID)0000-0003-1672-9560 (ORCID)0000-0002-6688-764X (ORCID)0000-0002-7653-8283 (ORCID)0000-0003-2913-1867 |
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breast cancer drugs: fda approval, development time, efficacy, clinical benefits, innovation, trials, endpoints, quality of life, value, and price |
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Breast cancer drugs: FDA approval, development time, efficacy, clinical benefits, innovation, trials, endpoints, quality of life, value, and price |
| abstract |
Objective This study analyzes the development, benefits, trial evidence, and price of new breast cancer drugs with US Food and Drug Administration (FDA) approval. Methods We identified 26 drugs with 42 FDA-approved indications for early and metastatic breast cancer (2000–2023). Data were collected from FDA labels, clinicaltrials.gov, and Medicare and Medicaid. Overall survival (OS) and progression-free survival (PFS) hazard ratios (HRs) and tumor response’s relative risk (RR) alongside objective response rate (ORR) were meta-analyzed. Results The median development time for breast cancer drugs was 7.8 years (95% CI 6.2–10.8). 26% of treatments were considered innovative (“first-in-indication”) with 88% acting via a targeted mechanism. 64% were small molecules, 19% antibodies, and 18% antibody-drug conjugates. 38% were approved for HR + and 31% for HER2 + breast cancer. 6 indications were for early and 36 for metastatic breast cancer. Indications utilized FDA’s special programs: orphan (2%), fast track (24%), accelerated approval (19%), priority review (74%), breakthrough therapy (44%). Approval was predominantly supported by phase 3 trials (88%) of randomized controlled design (66%), enrolling a median of 585 patients (IQR 417–752) at 181 centers (IQR 142–223) across 19 countries (IQR 17–20). New drugs’ HR were 0.78 for OS (95% CI 0.74–0.82) and 0.59 for PFS (95% CI 0.54–0.64) with a RR for tumor response of 1.61 (95% CI 1.46–1.76). Median improvements of OS were 2.8 months (IQR 1.8–5.8) and PFS were 4.4 months (IQR 2.2–7.1). In single-arm trials, the average ORR was 31% (95% CI 10–53). In meta-regressions, the correlation between OS/PFS was 0.34 (p = 0.031) and OS/response was 0.01 (p = 0.435). 60% of treatments had a ‘high-value’ ESMO-MCBS score with 14% demonstrating improvements in quality of life. The median price was $16,013 per month (95% CI 13,097–17,617). There was no association between prices and patient benefit. The median value per life year gained was $62,419 (IQR 25,840–86,062). Conclusions Over the past two decades, the development of innovative and effective drugs transformed the treatment landscape for breast cancer patients. Yet, investigators and regulators must safeguard that highly-priced new drugs demonstrate improvements in patient-centered clinical endpoints: overall survival and quality of life. © The Author(s) 2024 |
| abstractGer |
Objective This study analyzes the development, benefits, trial evidence, and price of new breast cancer drugs with US Food and Drug Administration (FDA) approval. Methods We identified 26 drugs with 42 FDA-approved indications for early and metastatic breast cancer (2000–2023). Data were collected from FDA labels, clinicaltrials.gov, and Medicare and Medicaid. Overall survival (OS) and progression-free survival (PFS) hazard ratios (HRs) and tumor response’s relative risk (RR) alongside objective response rate (ORR) were meta-analyzed. Results The median development time for breast cancer drugs was 7.8 years (95% CI 6.2–10.8). 26% of treatments were considered innovative (“first-in-indication”) with 88% acting via a targeted mechanism. 64% were small molecules, 19% antibodies, and 18% antibody-drug conjugates. 38% were approved for HR + and 31% for HER2 + breast cancer. 6 indications were for early and 36 for metastatic breast cancer. Indications utilized FDA’s special programs: orphan (2%), fast track (24%), accelerated approval (19%), priority review (74%), breakthrough therapy (44%). Approval was predominantly supported by phase 3 trials (88%) of randomized controlled design (66%), enrolling a median of 585 patients (IQR 417–752) at 181 centers (IQR 142–223) across 19 countries (IQR 17–20). New drugs’ HR were 0.78 for OS (95% CI 0.74–0.82) and 0.59 for PFS (95% CI 0.54–0.64) with a RR for tumor response of 1.61 (95% CI 1.46–1.76). Median improvements of OS were 2.8 months (IQR 1.8–5.8) and PFS were 4.4 months (IQR 2.2–7.1). In single-arm trials, the average ORR was 31% (95% CI 10–53). In meta-regressions, the correlation between OS/PFS was 0.34 (p = 0.031) and OS/response was 0.01 (p = 0.435). 60% of treatments had a ‘high-value’ ESMO-MCBS score with 14% demonstrating improvements in quality of life. The median price was $16,013 per month (95% CI 13,097–17,617). There was no association between prices and patient benefit. The median value per life year gained was $62,419 (IQR 25,840–86,062). Conclusions Over the past two decades, the development of innovative and effective drugs transformed the treatment landscape for breast cancer patients. Yet, investigators and regulators must safeguard that highly-priced new drugs demonstrate improvements in patient-centered clinical endpoints: overall survival and quality of life. © The Author(s) 2024 |
| abstract_unstemmed |
Objective This study analyzes the development, benefits, trial evidence, and price of new breast cancer drugs with US Food and Drug Administration (FDA) approval. Methods We identified 26 drugs with 42 FDA-approved indications for early and metastatic breast cancer (2000–2023). Data were collected from FDA labels, clinicaltrials.gov, and Medicare and Medicaid. Overall survival (OS) and progression-free survival (PFS) hazard ratios (HRs) and tumor response’s relative risk (RR) alongside objective response rate (ORR) were meta-analyzed. Results The median development time for breast cancer drugs was 7.8 years (95% CI 6.2–10.8). 26% of treatments were considered innovative (“first-in-indication”) with 88% acting via a targeted mechanism. 64% were small molecules, 19% antibodies, and 18% antibody-drug conjugates. 38% were approved for HR + and 31% for HER2 + breast cancer. 6 indications were for early and 36 for metastatic breast cancer. Indications utilized FDA’s special programs: orphan (2%), fast track (24%), accelerated approval (19%), priority review (74%), breakthrough therapy (44%). Approval was predominantly supported by phase 3 trials (88%) of randomized controlled design (66%), enrolling a median of 585 patients (IQR 417–752) at 181 centers (IQR 142–223) across 19 countries (IQR 17–20). New drugs’ HR were 0.78 for OS (95% CI 0.74–0.82) and 0.59 for PFS (95% CI 0.54–0.64) with a RR for tumor response of 1.61 (95% CI 1.46–1.76). Median improvements of OS were 2.8 months (IQR 1.8–5.8) and PFS were 4.4 months (IQR 2.2–7.1). In single-arm trials, the average ORR was 31% (95% CI 10–53). In meta-regressions, the correlation between OS/PFS was 0.34 (p = 0.031) and OS/response was 0.01 (p = 0.435). 60% of treatments had a ‘high-value’ ESMO-MCBS score with 14% demonstrating improvements in quality of life. The median price was $16,013 per month (95% CI 13,097–17,617). There was no association between prices and patient benefit. The median value per life year gained was $62,419 (IQR 25,840–86,062). Conclusions Over the past two decades, the development of innovative and effective drugs transformed the treatment landscape for breast cancer patients. Yet, investigators and regulators must safeguard that highly-priced new drugs demonstrate improvements in patient-centered clinical endpoints: overall survival and quality of life. © The Author(s) 2024 |
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Breast cancer drugs: FDA approval, development time, efficacy, clinical benefits, innovation, trials, endpoints, quality of life, value, and price |
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Michaeli, Thomas Trapani, Dario Albers, Sebastian Dannehl, Dominik Würstlein, Rachel Michaeli, Daniel Tobias |
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10.1007/s12282-024-01634-x |
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2024-10-19T04:51:58.824Z |
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Methods We identified 26 drugs with 42 FDA-approved indications for early and metastatic breast cancer (2000–2023). Data were collected from FDA labels, clinicaltrials.gov, and Medicare and Medicaid. Overall survival (OS) and progression-free survival (PFS) hazard ratios (HRs) and tumor response’s relative risk (RR) alongside objective response rate (ORR) were meta-analyzed. Results The median development time for breast cancer drugs was 7.8 years (95% CI 6.2–10.8). 26% of treatments were considered innovative (“first-in-indication”) with 88% acting via a targeted mechanism. 64% were small molecules, 19% antibodies, and 18% antibody-drug conjugates. 38% were approved for HR + and 31% for HER2 + breast cancer. 6 indications were for early and 36 for metastatic breast cancer. Indications utilized FDA’s special programs: orphan (2%), fast track (24%), accelerated approval (19%), priority review (74%), breakthrough therapy (44%). Approval was predominantly supported by phase 3 trials (88%) of randomized controlled design (66%), enrolling a median of 585 patients (IQR 417–752) at 181 centers (IQR 142–223) across 19 countries (IQR 17–20). New drugs’ HR were 0.78 for OS (95% CI 0.74–0.82) and 0.59 for PFS (95% CI 0.54–0.64) with a RR for tumor response of 1.61 (95% CI 1.46–1.76). Median improvements of OS were 2.8 months (IQR 1.8–5.8) and PFS were 4.4 months (IQR 2.2–7.1). In single-arm trials, the average ORR was 31% (95% CI 10–53). In meta-regressions, the correlation between OS/PFS was 0.34 (p = 0.031) and OS/response was 0.01 (p = 0.435). 60% of treatments had a ‘high-value’ ESMO-MCBS score with 14% demonstrating improvements in quality of life. The median price was $16,013 per month (95% CI 13,097–17,617). There was no association between prices and patient benefit. The median value per life year gained was $62,419 (IQR 25,840–86,062). 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| score |
7.4001913 |