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FDA approves pembrolizumab for recurrent or metastatic cutaneous squamous cell carcinoma

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The U.S. Food and Drug Administration has approved pembrolizumab (Keytruda) for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Approval was based on data from the Phase 2 KEYNOTE-629 trial that showed meaningful efficacy and durability of response with pembrolizumab.

Patients had an objective response rate (ORR) of 34%, including a complete response rate of 4% and a partial response rate of 31%. Of those who experienced a response, 69% had ongoing responses of six months or longer.

“Cutaneous squamous cell carcinoma is the second most common form of skin cancer,” said Dr. Jonathan Cheng, vice president, clinical research, Merck Research Laboratories, in a press release. “In KEYNOTE-629, treatment with KEYTRUDA resulted in clinically meaningful and durable responses. Today’s approval is great news for patients with cSCC and further demonstrates our commitment to bringing new treatment options to patients with advanced, difficult-to-treat cancers.”
 

Read the full press release here

 

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