FDA Approves Expanded Monotherapy Label for Merck’s KEYTRUDA® (pembrolizumab)
Merck & Company, Inc. (new) (MRK)
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Source: Business Wire
KEYTRUDA Now Approved for First-Line Treatment of Patients with Stage III NSCLC Who Are Not Candidates for Surgical Resection or Definitive Chemoradiation, or Metastatic NSCLC, and Whose Tumors Express PD-L1 (TPS =1%), with No EGFR or ALK Genomic Tumor Aberrations KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 (tumor proportion score [TPS] =1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. The approval is based on results from the Phase 3 KEYNOTE-04
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MRK
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- 4/25/24 - Beat
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- 4/11/24 - Form DEFA14A
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