FDA and EMA Approvals of New Breast Cancer Drugs-A Comparative Regulatory Analysis

Chandra P Leo; Bettina Hentschel; Thomas D Szucs; Cornelia Leo

doi:10.3390/cancers12020437

FDA and EMA Approvals of New Breast Cancer Drugs-A Comparative Regulatory Analysis

Cancers (Basel). 2020 Feb 13;12(2):437. doi: 10.3390/cancers12020437.

Authors

Chandra P Leo¹, Bettina Hentschel², Thomas D Szucs³, Cornelia Leo⁴

Affiliations

¹ HBM Partners, 6300 Zug, Switzerland.
² Institute for Medical Informatics, Statistics and Epidemiology (IMISE), University Leipzig, 04107 Leipzig, Germany.
³ European Center for Pharmaceutical Medicine, University of Basel, 4056 Basel, Switzerland.
⁴ Interdisciplinary Breast Center, Kantonsspital Baden, 5404 Baden, Switzerland.

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.

Keywords: EMA; European Medicines Agency; FDA; Food and Drug Administration; breast cancer; drug approvals; drug devFelopment; oncology; regulatory affairs.