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FDA Grants Priority Review to sBLA for Pembrolizumab in Merkel Cell Carcinoma

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The U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental biologics license application (sBLA) seeking accelerated approval for pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.

This sBLA is based on data from the phase II KEYNOTE-017 trial, including overall response rate and duration of response; these data were presented earlier this year at the 2018 ASCO Annual Meeting (Abstract 9506). In July 2017, pembrolizumab was granted Breakthrough Therapy designation by the FDA for this indication.

The FDA has set a Prescription Drug User Fee Act, or target action, date of December 28, 2018.

About Merkel Cell Carcinoma

Merkel cell carcinoma is an aggressive and rare form of skin cancer that is often caused by a Merkel cell–associated polyomavirus. More than 90% of people diagnosed with Merkel cell carcinoma are older than 50 years of age. Merkel cell carcinoma is more likely to spread to other parts of the body than most types of skin cancer. It is estimated that about 2,500 cases of Merkel cell carcinoma are diagnosed each year in the United States, which has the highest incidence of the disease along with Australia and New Zealand. Historically, Merkel cell carcinoma has an 18-month survival rate of about 30%.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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