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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).>0.0027])>
Condition: Hodgkin Lymphoma
Type: drug