Merck Withdraws U.S. Indication for KEYTRUDA
02 March 2021 - 9:05AM
Dow Jones News
By Adriano Marchese
Merck & Co. said Monday that it is voluntarily withdrawing
the U.S. indication for KEYTRUDA for the treatment of patients with
metastatic small cell lung cancer after failing to meet an endpoint
in its phase three trials.
The company said the withdrawal of the indication of KEYTRUDA--a
therapy also known as pembrolizumab--was done in consultation with
the Food and Drug Administration, and Merck expects to complete the
process over the coming weeks.
The company noted that phase three trials met only one of its
dual primary endpoints, failing reach statistical significance for
the other endpoint.
Write to Adriano Marchese at adriano.marchese@wsj.com
(END) Dow Jones Newswires
March 01, 2021 16:50 ET (21:50 GMT)
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