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Merck & Co.'s Keytruda gets US FDA priority tag for skin cancer indication


According to Market Intelligence, December 2022


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Merck & Co.'s Keytruda gets US FDA priority tag for skin cancer indication

Merck & Co. Inc. said the U.S. Food and Drug Administration granted priority review to its blockbuster drug Keytruda for treating a type of skin cancer.

The U.S. regulator accepted the Kenilworth, N.J.-based company's supplemental biologics license application seeking accelerated approval for Keytruda for treating adults and children with Merkel cell carcinoma whose cancers have spread across the body.

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Keytruda is a checkpoint inhibitor — a tumor-targeting drug that blocks the PD-1 arm on healthy cells from linking up with a partner arm on the surface of cancer cells to spread the disease.

The designation is based on data from the phase 2 Keynote-017 trial. The regulator is expected to decide on the drug's approval for the skin cancer indication by Dec. 28.

Keytruda was also granted U.S. FDA breakthrough therapy designation for the same indication in July 2017. Keytruda is approved in the U.S., EU and other countries as a single treatment or in combination with other therapies for a myriad of other cancers.

Merkel cell carcinoma is an aggressive and rare form of skin cancer that is caused by a Merkel cell associated polyomavirus. About 2,500 cases of the disease are estimated to be diagnosed each year in the U.S.