The FDA has accepted two supplemental Biologics License Applications for Merck’s Keytruda (pembrolizumab) for treatment of triple-negative breast cancer (TNBC) and has granted one of them a priority review.
The agency granted priority review for the blockbuster cancer drug in combination with chemotherapy for patients with locally recurrent unresectable or metastatic TNBC whose tumors express the PD-L1 protein. The agency is expected to issue a decision on the application by Nov. 28, 2020.
Keytruda is also under review for patients with high-risk early-stage TNBC in combination with chemotherapy, and then alone as adjuvant treatment after surgery. The FDA is expected to make a decision on this application by March 29, 2021.