Trends in Breast Cancer Drugs Approved by the US Food and Drug Administration, 1980-2024
Author(s)
Daniel O. Umoru, B.Pharm1, Choi Wonsuk, M.S.2, Enrique Seoane-Vazquez, PhD1, Lawrence Brown, PharmD, Ph.D.1;
1Chapman University School of Pharmacy, Pharmaceutical Economics and Policy, Irvine, CA, USA, 2Chapman University School of Pharmacy, Biomedical and Pharmaceutical Science, Irvine, CA, USA
1Chapman University School of Pharmacy, Pharmaceutical Economics and Policy, Irvine, CA, USA, 2Chapman University School of Pharmacy, Biomedical and Pharmaceutical Science, Irvine, CA, USA
Presentation Documents
OBJECTIVES: Breast cancer is the most common cancer among women and the leading cause of cancer death among women. The pharmacological options for breast cancer include chemotherapy, hormone therapy, targeted therapy, and immunotherapy, which are used for the prevention or treatment of breast cancer. This study assessed the characteristics and trends in the FDA approval of drug for breast cancer from 1980 to 2024.
METHODS: We collected regulatory information from the drugs@FDA, FDA Label Search, and DailyMeds databases. We assessed trends in the number of approvals, FDA review time, and regulatory procedures and designations analyses using Microsoft Excel and Python 3.13.1.
RESULTS: The FDA approved 68 drugs for breast cancer in 1980-2024, including 49 new molecular entities and 19 new biologics. The FDA approved 46 (67.6%) drugs using priority review designation, 14 (20.6%) used accelerated approval pathways, and 9 (13.2%) drugs were granted orphan designation. The indications were approved by the FDA for Stages 1 (12,11.8%), 2 (18, 17.6%), 3 (23, 22.5%), and 4 (49, 48.0%). The FDA review time decline over time from an average ± standard deviation of 13.01 ± 13.43 months from 1980 to PDUFA 1 in 1992 to 9.51 ± 5.85 months in 1992-2024. The FDA review time varied by cancer stage from 9.0 ± 2.9 for Stage 1 to 9.5 ± 6.1 for Stage 4.
CONCLUSIONS: The FDA approved more than 3 drugs per year for breast cancer treatment and prevention. Most drugs approved after 2000 were indicated for late-stage breast cancer. Most drugs were approved using priority review and only a few were granted orphan drug designation. The FDA review time for breast cancer drugs declined over time.
METHODS: We collected regulatory information from the drugs@FDA, FDA Label Search, and DailyMeds databases. We assessed trends in the number of approvals, FDA review time, and regulatory procedures and designations analyses using Microsoft Excel and Python 3.13.1.
RESULTS: The FDA approved 68 drugs for breast cancer in 1980-2024, including 49 new molecular entities and 19 new biologics. The FDA approved 46 (67.6%) drugs using priority review designation, 14 (20.6%) used accelerated approval pathways, and 9 (13.2%) drugs were granted orphan designation. The indications were approved by the FDA for Stages 1 (12,11.8%), 2 (18, 17.6%), 3 (23, 22.5%), and 4 (49, 48.0%). The FDA review time decline over time from an average ± standard deviation of 13.01 ± 13.43 months from 1980 to PDUFA 1 in 1992 to 9.51 ± 5.85 months in 1992-2024. The FDA review time varied by cancer stage from 9.0 ± 2.9 for Stage 1 to 9.5 ± 6.1 for Stage 4.
CONCLUSIONS: The FDA approved more than 3 drugs per year for breast cancer treatment and prevention. Most drugs approved after 2000 were indicated for late-stage breast cancer. Most drugs were approved using priority review and only a few were granted orphan drug designation. The FDA review time for breast cancer drugs declined over time.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
HPR107
Topic
Health Policy & Regulatory
Topic Subcategory
Approval & Labeling, Coverage with Evidence Development & Adaptive Pathways
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Oncology