By Colin Kellaher
Bristol Myers Squibb has won Food and Drug Administration priority review for its application seeking approval of the combination of its Opdivo and Yervoy cancer drugs for the early treatment of certain patients with colorectal cancer.
Bristol Myers on Monday said the application covers the combination as a potential first-line treatment for patients 12 years old and older with unresectable or metastatic microsatellite instability-high or mismatch-repair-deficient colorectal cancer.
The FDA in 2018 approved the combination for the same patient population whose cancer had progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan.
Bristol Myers said about 5% to 7% of people with metastatic colorectal cancer have microsatellite instability-high or mismatch-repair-deficient tumors, adding that these patients are less likely to benefit from conventional chemotherapy and typically have a poor prognosis.
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. Princeton, N.J., drugmaker Bristol Myers said the agency has set a target action date of June 23 for its application.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 24, 2025 07:20 ET (12:20 GMT)
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