Industry News Archive

FDA Approves Additional Indication for Pembrolizumab

Pembrolizumab (Keytruda®, Merck) has received FDA approval, in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express programmed death ligand 1 (PD-L1) [combined positive score (CPS ≥10)] as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Select patients for treatment with KEYTRUDA in combination with chemotherapy based on the presence of positive PD-L1 expression in:
- locally recurrent unresectable or metastatic TNBC

Read prescribing information and Medication Guide.

Posted on 12/07/2020


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