Bristol Myers Gets FDA Priority Review for Two Opdivo Indications
January 20 2021 - 7:51AM
Dow Jones News
By Colin Kellaher
Bristol Myers Squibb Co. on Wednesday said the U.S. Food and
Drug Administration granted priority review to a pair of
applications for expanded use of its blockbuster cancer drug
Opdivo.
The New York biopharmaceutical company said the FDA set a target
action date of May 20 for its application for Opdivo for patients
with resected esophageal or gastroesophageal junction cancer in the
adjuvant setting, after neoadjuvant chemoradiation therapy.
Bristol Myers said the agency set a target action date of May 25
for its application for Opdivo, in combination with
fluoropyrimidine- and platinum-containing chemotherapy, for
patients with advanced or metastatic gastric cancer,
gastroesophageal junction cancer or esophageal adenocarcinoma.
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.
Opdivo, which harnesses the body's own immune system to fight
cancer, is currently approved in more than 65 countries across
multiple cancers.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
January 20, 2021 07:36 ET (12:36 GMT)
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