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New FDA Approval for KEYTRUDA

Merck is pleased to announce that KEYTRUDA, in combination with platinum and fluorouracil (FU), has been approved by the FDA for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA has also been approved by the FDA as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) ≥1] as determined by an FDA-approved test.

PD-L1 diagnostic testing is required prior to initiating monotherapy with KEYTRUDA in patients with metastatic or with unresectable, recurrent HNSCC.

Prior Indication:

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

This prior indication has not changed.

FDA=Food and Drug Administration; PD-L1=programmed death ligand 1

Before prescribing KEYTRUDA® (pembrolizumab), please read the Prescribing Information.
The Medication Guide also is available.