FDA to speed Opdivo review for use as colorectal cancer drug
Opdivo, an immune-enhancing drug approved for skin, lung and other types of cancer, will begin an accelerated assessment process to win FDA approval to treat specific types of colorectal cancer.
Bristol-Myers Squibb (BMS) said in an April 4 release that the FDA agreed to speed the review process for its Opdivo, which may see the medicine greenlighted by August.
Specifically, BMS is seeking to treat tumors containing mistakes in a patient’s DNA, which often fail to respond to one of three different chemotherapy drugs, the release said.
Dr. Ian M. Waxman, BSM’s development lead for gastrointestinal oncology, said in the release that expanding Opdivo’s approved uses aligns with the firm’s advancement of immuno-oncology.
“These patients have a distinct unmet need, as they are less likely to benefit from conventional chemotherapy and have a shorter overall survival than patients with metastatic colorectal cancer without these biomarkers,” Waxman said.
Nationwide, colorectal cancer ranks No. 2 in fatalities, diagnosed in more than 130,000 new patients each year, the release said.
Organizations in this story
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U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD 20903