Bristol-Myers Gets FDA Priority Review for Opdivo/Yervoy for Non-Small Cell Lung Cancer
January 15 2020 - 7:53AM
Dow Jones News
By Colin Kellaher
Bristol-Myers Squibb Co. (BMY) said Wednesday the U.S. Food and
Drug Administration accepted for priority review its supplemental
biologics license application for Opdivo in combination with Yervoy
for the treatment of a form of lung cancer.
The New York biopharmaceutical company said the filing covers
the first-line treatment of patients with metastatic or recurrent
non-small cell lung cancer with no EGFR or ALK genomic tumor
aberrations.
Non-small cell lung cancer is one of the most common types of
lung cancer, accounting for up to 85% of diagnoses.
Bristol-Myers said the FDA set a target action date of May 15
for the application.
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.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
January 15, 2020 07:38 ET (12:38 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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