FDA approves expanded label for Keytruda in relapsed or refractory classical Hodgkin lymphoma.- Merck Inc

Merck Inc announced that the FDA has approved an expanded label for Keytruda (pembrolizumab), 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 III 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 bv. additionally median progression-free survival pfs was 13.2 months 95 ci 10.9-19.4 for patients treated with keytruda and 8.3 months 95 ci 5.7-8.8 for patients treated with bv. the fda also approved an updated pediatric indication for keytruda for the treatment of pediatric patients with refractory chl or chl that has relapsed after two or more lines of therapy. immune-mediated adverse reactions which may be severe or fatal can occur with keytruda including pneumonitis colitis hepatitis endocrinopathies nephritis severe skin reactions solid organ transplant rejection and complications of allogeneic hematopoietic stem cell transplantation hsct.>