Bristol Myers Gets Positive CHMP Opinion for Opdivo in Gastric, Esophageal Cancers
September 17 2021 - 7:45AM
Dow Jones News
By Colin Kellaher
Bristol Myers Squibb Co. on Friday said the European Medicines
Agency's Committee for Medicinal Products for Human Use recommended
expanded approval of its cancer drug Opdivo in certain cancers of
the stomach and esophagus.
The New York biopharmaceutical company said the recommendation
covers Opdivo in combination with fluoropyrimidine and
platinum-containing chemotherapy for the first-line treatment of
adults with HER2-negative advanced or metastatic gastric,
gastroesophageal junction or esophageal adenocarcinoma whose tumors
express PD-L1 with a combined positive score of at least 5.
Bristol Myers said the recommendation is based on results from a
Phase 3 study in which Opdivo plus chemotherapy showed superior
overall survival versus chemotherapy alone.
The European Commission, which generally follows CHMP's advice,
will now review the recommendation.
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
September 17, 2021 07:30 ET (11:30 GMT)
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