Bristol Myers: CHMP Backs Opdivo/Cabometyx in Advanced Renal Cell Carcinoma
February 26 2021 - 7:27AM
Dow Jones News
By Colin Kellaher
Bristol Myers Squibb Co. Friday said the European Medicines
Agency's Committee for Medicinal Products for Human Use recommended
approval of its cancer drug Opdivo in combination with Cabometyx
for the first-line treatment of adults with advanced renal cell
carcinoma.
The New York biopharmaceutical company said the recommendation
is based on a Phase 3 study in which the combination doubled
progression-free survival and significantly improved overall
survival and response rates.
The European Commission, which generally follows CHMP's advice,
will now review the recommendation.
Alameda, Calif., biopharmaceutical company Exelixis Inc.
discovered Cabometyx and holds exclusive U.S. rights. French drug
maker Ipsen has exclusive rights for the commercialization and
further clinical development of the drug outside of the U.S. and
Japan under a 2016 deal with Exelixis.
The U.S. Food and Drug Administration in January approved the
novel combination of Opdivo and Cabometyx as a first-line treatment
of advanced renal cell carcinoma, the most common form of kidney
cancer.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 26, 2021 07:12 ET (12:12 GMT)
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