Merck's Keytruda Expanded Label Approved by FDA
July 06 2021 - 7:30AM
Dow Jones News
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 robb.stewart@wsj.com
(END) Dow Jones Newswires
July 06, 2021 07:15 ET (11:15 GMT)
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