Posted by Michael Wonder on 15 Oct 2020
FDA approves expanded indication for Merck’s Keytruda (pembrolizumab) in adult patients with relapsed or refractory classical Hodgkin lymphoma
15 October 2020 - Keytruda is the first anti-PD-1 therapy approved for adult patients with relapsed or refractory classic Hodgkin lymphoma after frontline therapy.
Merck today announced that the U.S. 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.
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<0.0027]) compared to brentuximab vedotin.
