Merck & Co clocks Keytruda approval in relapsed or refractory cHL

The US Food and Drug Administration (FDA) has approved an expanded label for Keytruda (pembrolizumab), Merck & Co’s (NYSE: MRK) anti-PD-1 therapy, as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin's 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% compared to brentuximab vedotin (BV). Additionally, median progression-free survival was 13.2 months for patients treated with Keytruda and 8.3 months for patients treated with BV.

"Keytruda has the potential to change the current standard of care"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, has also been approved by the FDA.