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FDA Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) in Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)

Published: 2020-10-15 10:45:00 ET
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KEYTRUDA Is the First Anti-PD-1 Therapy Approved for Adult Patients With Relapsed or Refractory cHL After Frontline Therapy

KEYTRUDA Also Approved for Pediatric Patients With Refractory cHL, or cHL That Has Relapsed After Two or More Lines of Therapy

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 treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). The approval is based on results from the Phase 3 KEYNOTE-204 trial in which KEYTRUDA significantly reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.48-0.88; p