Merck Gets FDA Priority Review for Second Application for Keytruda Based on Biomarker

By Colin Kellaher

Merck & Co. on Tuesday said the U.S. Food and Drug Administration granted priority review for a new supplemental biologics license application for its cancer drug Keytruda based on a biomarker, regardless of tumor type.

The Kenilworth, N.J., drug maker said the application seeks accelerated approval of Keytruda monotherapy in patients whose tumors are tumor mutational burden-high and who have progressed following prior treatment.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period to six months from the standard 10 months. Merck said the agency set a target action date of June 16 for the application.

The FDA in 2017 approved Keytruda as the first cancer treatment based on a biomarker, regardless of cancer type, in microsatellite instability-high or mismatch repair deficient solid tumors.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

April 07, 2020 07:42 ET (11:42 GMT)

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