Merck has announced the FDA’s approval of Keytruda’s indication for treatment in classical Hodgkin lymphoma (cHL) patients.
Merck has announced the FDA’s approval of Keytruda’s indication for treatment in classical Hodgkin lymphoma (cHL) patients. Keytruda (pembrolizumab) is approved for use in adult patients at a fixed dose of 200 mg and in pediatric patients at a dose of 2 mg/kg with refractory or relapsed cHL.
This indication is based on tumor response rate and durability of response evaluated in a clinical trial. The trial included 210 patients who demonstrated an overall response rate of 69% with a complete remission rate of 22% and a partial remission rate of 47%.
Pembrolizumab is already approved to treat advanced non-small cell lung cancer, advanced melanoma, and head and neck squamous cell cancer.
“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 Moskowitz, MD, clinical director, division of hematologic oncology of Memorial Sloan Kettering Cancer Center, said in a press release. “This approval is an important step forward in treating these patients, who are generally young and have a particularly poor prognosis, and gives us opportunity to help patients in their fight against this devastating disease.”
Keytruda is administered intravenously every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.
FDA Approves Merck’s Keytruda ® (pembrolizumab) for adult and pediatric patients with classical hodgkin lymphoma (cHL) refractory to treatment, or who have relapsed after 3 or more prior lines of therapy [news release]. New Jersey. Merck’s website. http://www.mrknewsroom.com/news-release/corporate-news/fda-approves-mercks-keytruda-pembrolizumab-adult-and-pediatric-patients-. Accessed March 15, 2017.