FDA Grants Priority Review to Merck’s Application for KEYTRUDA® (pembrolizumab) Monotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer in Patient...
Merck & Company, Inc. (new) (MRK)
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Source: Business Wire
Application Based on Overall Survival Data from Pivotal Phase 3 KEYNOTE-042 Trial 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 accepted for review and granted priority review to a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for first-line treatment of locally advanced or metastatic nonsquamous or squamous non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 (tumor proportion score [TPS] =1%) without EGFR or ALK genomic tumor aberrations. The application is based on data from the pivotal Phase 3 KEYNOTE-042 trial, one of five Phase 3 clinical trials with KEYTRUDA in NSCLC to demonstrate a significant improvement in overall survival. Data from the trial were presented earlier
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MRK
Earnings
- 4/25/24 - Beat
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Sec Filings
- 5/6/24 - Form 144
- 5/6/24 - Form 4
- 5/6/24 - Form 4
- MRK's page on the SEC website