FDA grants priority review to Keytruda for Hodgkin lymphoma subset
The FDA granted priority review to pembrolizumab for the second-line treatment of patients with relapsed or refractory classical Hodgkin lymphoma, according to a press release from the agent’s manufacturer.
The anti-PD-1 therapy pembrolizumab (Keytruda, Merck) is FDA approved for treatment of adults and children with refractory classical Hodgkin lymphoma who relapsed after three or more prior lines of therapy.
The agency based the priority review decision, in part, on data from the randomized, open-label phase 3 KEYNOTE-204 trial, which included 304 adults with relapsed or refractory classical Hodgkin lymphoma. Researchers randomly assigned patients to 200 mg IV pembrolizumab or to 1.8 mg/kg IV brentuximab vedotin (Adcetris, Seattle Genetics) on day 1 of each 3-week cycle for up to 35 cycles.
PFS and OS served as dual primary endpoints.
As Healio previously reported, data presented during the ASCO20 Virtual Scientific Program showed pembrolizumab significantly extended median PFS compared with brentuximab vedotin, an antibody-drug conjugate directed at CD30 that serves as the standard of care for this population (13.2 months vs. 8.3 months; HR = 0.65; 95% CI, 0.48-0.88).
OS has not yet been formally tested.
“Classical Hodgkin lymphoma accounts for more than nine in 10 cases of Hodgkin lymphoma, which impacts approximately 7,400 patients a year in the U.S. For patients with classical Hodgkin lymphoma who do not achieve remission after first-line treatment, there is a particularly poor prognosis due to the limited options available,” Jonathan Cheng, MD, vice president of oncology clinical research at Merck Research Laboratories, said in the release. “We look forward to working with the FDA to bring Keytruda to more patients with classical Hodgkin lymphoma after initial treatment.”
The FDA is expected to decide on this application by Oct. 30.