Abstract
Breast cancer is the most common cancer in women worldwide and the solid tumor type for which the highest number of drugs have been approved to date. This study examines new drug approvals for breast cancer by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), based on an analysis of regulatory documents from both agencies for the period from 1995 to 2018. Of the 29 breast cancer drugs approved over this time span, 17 received positive decisions from both the FDA and EMA, including all drugs licensed after 2008. Nineteen of the 25 FDA-approved drugs, but none of the EMA approvals, benefited from special regulatory pathways (such as fast track, breakthrough therapy, or priority review). In the U.S.A., four accelerated approvals were granted (of which one, for bevacizumab, was later revoked), while only two drugs received provisional approvals following EMA review. New breast cancer drugs were approved approximately twelve months earlier in the United States than in Europe. These results suggest that a broader use of special regulatory pathways by EMA could help to accelerate access to novel drugs for European breast cancer patients.
Highlights
Breast cancer is the most common malignancy diagnosed in women, accounting for a quarter of all new cancer cases in the female population [1]
We found that the rate of new drug approvals for breast cancer has dramatically increased over the last 30 years, compared to earlier decades, in part driven by the development of targeted therapeutics [3]
If one includes the field of hematologic oncology, breast cancer resides in third place, behind leukemias and lymphomas
Summary
Breast cancer is the most common malignancy diagnosed in women, accounting for a quarter of all new cancer cases in the female population [1]. We found that the rate of new drug approvals for breast cancer has dramatically increased over the last 30 years, compared to earlier decades, in part driven by the development of targeted therapeutics [3]. This trend matches the acceleration of new drug approvals seen across the field of oncology as a whole [4,5], which results from the impressive progress in translational cancer research and from the evolving regulatory environment [6,7]. These factors have profoundly changed the way in which new cancer drugs are discovered, studied, reviewed, and approved [8,9,10]
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