By Colin Kellaher
Merus on Tuesday said the Food and Drug Administration extended its review of the clinical-stage oncology company's proposed zenocutuzumab cancer treatment.
Merus said the FDA set a new target action date of Feb. 4 after the Utrecht, Netherlands, company submitted information in response to an agency request related to chemistry, manufacturing and controls.
Merus, which is seeking approval of zenocutuzumab in certain patients with non-small cell lung and pancreatic cancer, noted that the FDA didn't request any additional clinical data.
The FDA in May granted priority review, which typically entails a six-month review, to Merus's application for zenocutuzumab.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
November 05, 2024 08:17 ET (13:17 GMT)
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