FDA grants priority review to Keytruda in Hodgkin lymphoma.- Merck Inc

Merck Inc announced that the FDA has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab), as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

This sBLA is based on data from the pivotal Phase III KEYNOTE-204 trial, in which Keytruda demonstrated a significant improvement in progression-free survival (PFS) compared to brentuximab vedotin (BV), a current standard of care in this patient population. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Oct. 30, 2020.

KEYNOTE-204 also serves as the confirmatory trial for the Keytruda accelerated approval hematology indications. Data from KEYNOTE-204 were recently presented at the 2020 American Society of Clinical Oncology Annual Meeting.