FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Merck’s Keytruda Earns FDA Approval for Rare Skin Cancer

Jan. 2, 2019
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Merck’s cancer treatment Keytruda (pembrolizumab) has been approved by the FDA for treating a rare type of skin cancer in adult and pediatric patients.

The blockbuster cancer drug is now cleared to treat adults and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma, a rare type of skin cancer that typically appears as a flesh or bluish-red colored nodule on the face, neck or head.

The indication was given under accelerated approval based on tumor response rate and response durability, and its continued approval may hinge on confirming its clinical benefit in subsequent trials.

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