Bristol Myers Squibb : Gets FDA Priority Review for Two Opdivo Indications

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 [e-mail]

(END) Dow Jones Newswires

01-20-21 0736ET