FDA Approves Pembrolizumab to Treat Merkel Cell Carcinoma

The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). 

The decision was based on results of the multicenter, non-randomized, open-label KEYNOTE-017 trial, which included 50 patients with recurrent locally advanced or metastatic MCC who had not received prior systemic therapy for advanced disease. Patients received pembrolizumab 2 mg/kg every three weeks. 

.@US_FDA Approves Pembrolizumab for Merkel Cell Carcinoma https://t.co/mLgCgbjr8F #skcsm #oncology

— The ASCO Post (@ASCOPost) December 19, 2018

The overall response rate was 56% (95% CI, 41-70), with a complete response rate of 24%. The median response duration was not reached. Among the 28 responders, 96% had a duration of response of more than 6 months and 54% had duration of response of more than 12 months. 

The most common adverse events associated with pembrolizumab monotherapy included fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, and abdominal pain. 

FDA granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co. Inc.) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma https://t.co/a5lFffH67P

— FDA Oncology (@FDAOncology) December 19, 2018

The recommended pembrolizumab dose for MCC is 200 mg administered as a 30-minute intravenous (IV) infusion every three weeks for adults and 2 mg/kg (maximum of 200 mg) administered as a 30-minute IV infusion every three weeks for pediatric patients (younger than 18 years). 

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Source: FDA