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Merck Announces FDA Approval Of Two New Indications For KEYTRUDA - Quick Facts

Merck (MRK) said the FDA has approved KEYTRUDA as monotherapy in patients whose tumors express PD-L1 or in combination with platinum and fluorouracil for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma. The approval of the new indications are based on data from the pre-specified interim analysis of the Phase 3 KEYNOTE-048 trial.

Based on the clinical benefit observed in the KEYNOTE-048 trial, the FDA converted the accelerated approval granted in 2016 for KEYTRUDA for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy, to a full approval.

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