US FDA Drug Approvals for Breast Cancer: A Decade in Review

Over the last decade, the treatment of patients with breast cancer has been greatly impacted by the approval of multiple drugs and indications. This summary describes 30 FDA approvals of treatments for breast cancer from 2010 to 2020. The trial design endpoints, results, and regulatory considerations are described for each approved indication. Of the 30 indications, 23 (76.6%) received regular and 7 (23.3%) received accelerated approval. Twenty-six approvals were granted in metastatic breast cancer (MBC) and four in early breast cancer. Approval decisions for the 26 MBC indications were initially supported by progres-sion-free survival (PFS) in 21 (80.8%), overall survival (OS) or a combination of OS and PFS in two (7.7%), and objective response rate (ORR) in three (11.5%). The four approvals in early breast cancer utilized pathologic complete response (pCR) in one (25%) and invasive disease-free survival (iDFS) in three (75%) trials. Among the 30 indications, 22 received priority review, seven were granted Breakthrough Therapy Designation, and 10 applications participated in one or more pilot Oncology Center of Excellence regulatory review initiatives, including Real Time Oncology Review, Assessment Aid, and Project Orbis. FDA initiatives to advance breast cancer drug development are also described.

Automated summary

The treatment of patients with breast cancer has been greatly influenced by the approval of various drugs and indications in the past decade. This article summarizes the FDA approvals of 30 treatments for breast cancer from 2010 to 2020, including trial design, results, and regulatory considerations. The majority of approvals were for metastatic breast cancer, with a smaller number for early breast cancer. These approvals were primarily based on progression-free survival, overall survival, or objective response rate, and also involved other review initiatives and designations.