Merck's Keytruda Expanded Label Approved by FDA

By Robb M. Stewart

Merck & Co. on Tuesday said the U.S. Food and Drug Administration has approved an expanded label for cancer medicine Keytruda as a monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma that isn't curable by surgery or radiation.

The expanded indication reinforces the role of Keytruda in this cancer type, which is the second most common form of non-melanoma skin cancer, said Vicki Goodman, vice president of clinical research at Merck Research Laboratories.

Merck said the approval is based on data from the second interim analysis of its Phase 2 Keynote-629 trial, in which Keytruda demonstrated an objective response rate of 50%, including a complete response rate of 17% and a partial response rate of 33% in the cohort of patients with locally advanced disease. Among the 27 responding patients, 81% had a duration of response of six months or longer, and 37% had a duration of response of 12 months or longer, it said.

In June 2020, Keytruda was granted its first indication in cutaneous squamous cell carcinoma as a monotherapy for the treatment of patients with recurrent or metastatic disease that isn't curable by surgery or radiation.

Write to Robb M. Stewart at [e-mail]

(END) Dow Jones Newswires

July 06, 2021 07:15 ET (11:15 GMT)

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