FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) in Certain Patients with High-Risk, Non-Muscle Invasive Bladder Cancer (NMIBC)
Dateline City:
KENILWORTH, N.J.
Application Based on Results from Phase 2 KEYNOTE-057 Trial, to be Discussed at December FDA Oncologic Drugs Advisory Committee (ODAC) Meeting
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 and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy.
Language:
English
Contact:
Media Contacts:
Pamela Eisele
(267) 305-3558
Kristen Drake
(908) 740-6179
Investor Contacts:
Peter Dannenbaum
(908) 740-1037
Michael DeCarbo
(908) 740-1807
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MRK
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NYSE
@Merck
