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FDA Approves Keytruda for Classical Hodgkin Lymphoma
Merck news release; 2017 Mar 14
The FDA granted accelerated approval of Keytruda for the treatment of classical Hodgkin lymphoma (cHL).
Indications: Keytruda is a programmed death receptor-1-blocking antibody indicated for the treatment of adult and pediatric patients with refractory cHL, or who have relapsed after 3 or more prior lines of therapy.
Dosage and administration: 200 mg every 3 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatric patients.
Efficacy and safety: Approval is based on data from the KEYNOTE-087 trial, which demonstrated an overall response rate with Keytruda of 69%, with a complete remission rate of 22%, and a partial remission rate of 47%.
Side effects/risks: Most common adverse reactions were fatigue, pruritus, diarrhea, decreased appetite, rash, pyrexia, cough, dyspnea, musculoskeletal pain, constipation, and nausea.
FDA approves Merck’s Keytruda (pembrolizumab) for adult and pediatric patients with classical Hodgkin lymphoma (chl) refractory to treatment, or who have relapsed after three or more prior lines of therapy. [news release]. Kenilworth, NJ: Merck; March 14, 2017. http://www.mercknewsroom.com/news-release/corporate-news/fda-approves-mercks-keytruda-pembrolizumab-adult-and-pediatric-patients. Accessed March 20, 2017.
Keytruda [package insert]. Whitehouse Station, NJ: Merck & Co., Inc. 2017. http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf. Accessed March 20, 2017.