Policy & Regulation
FDA Approves Expanded Indication for Merck's KEYTRUDA (pembrolizumab) in Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
16 October 2020 - - The US Food and Drug Administration has approved an expanded label for Keytruda, US-based pharmaceutical company Merck's (NYSE: MRK) anti-PD-1 therapy, as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma, the company said.

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


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