Merck Gets FDA Priority Review for Second Application for Keytruda Based on Biomarker
April 07 2020 - 7:57AM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
April 07, 2020 07:42 ET (11:42 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
Merck (NYSE:MRK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Merck (NYSE:MRK)
Historical Stock Chart
From Apr 2023 to Apr 2024