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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