Posted by Michael Wonder on 09 Jul 2020
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) for second-line treatment of patients with relapsed or refractory classical Hodgkin lymphoma
9 July 2020 - Application based on data comparing Keytruda to standard care (brentuximab vedotin) from pivotal Phase 3 KEYNOTE-204 trial.
Merck today announced that the U.S. FDA has accepted and granted priority review for a new supplemental biologics license application for Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma.
This application is based on data from the pivotal Phase 3 KEYNOTE-204 trial, in which Keytruda demonstrated a significant improvement in progression-free survival compared to brentuximab vedotin, a current standard of care in this patient population. The FDA has set a Prescription Drug User Fee Act, or target action, date of 30 October 2020.
