Pembrolizumab is now approved for the treatment of adults and children who have refractory classical Hodgkin lymphoma, or who have relapsed after three or more prior lines of therapy, the Food and Drug Administration announced on March 14.
Pembrolizumab (Keytruda) is a humanized monoclonal antibody administered intravenously. According to a press release from Merck, the manufacturer of Keytruda, the approval is based on data from 210 patients aged 18 years and older in the KEYNOTE-087 trial , which found an overall response rate of 69% among patients who received 200 mg of the drug every 3 weeks. Among responders, the median duration of response was 11.1 months.
The complete remission rate was 22% and the partial remission rate was 47%. The median follow-up time in the study was 9.4 months.
“For the patients with classical Hodgkin lymphoma who are not cured with existing treatments, there are limited options, and treating their disease becomes more challenging,” Craig H. Moskowitz, MD, clinical director of the division of hematologic oncology at Memorial Sloan Kettering Cancer Center, New York, said in the press release. “This approval is an important step forward in treating these patients, who are generally young and have a particularly poor prognosis.”
According to Merck, continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The revised drug label information can be found here .