The U.S. Food and Drug Administration (FDA) is set to decide in September whether Opdivo, Bristol-Myers Squibb’s cancer drug, can be used to treat malignancies of the liver as a follow up to another medicine, sorafenib.
Bristol-Myers Squibb said the FDA action on its petition for accelerated review was made on the heels of data from Checkmate, a Phase1/2 clinical trial assessing Opdivo’s efficacy with hepatitis sufferers.
Dr. Ian Waxman, development lead of Bristol-Myers Squibb’s gastrointestinal cancer division, said FDA’s decision as a boon for early detection and treatment of liver cancers.
“We believe the FDA acceptance of our application for Opdivo with priority review status is an important recognition of the significant unmet need for patients with HCC (hepatocellular carcinoma), which is often diagnosed in the advanced stage when treatment options are limited,” Waxman said in a press release. “We are committed to exploring new treatment options for these patients and look forward to working with the FDA to potentially extend the use of Opdivo as a treatment option in this setting.”
Findings from the CheckMate study, to be presented at the annual meeting of the American Society of Clinical Oncology in June, investigated Opdivo’s use in liver cancer patients with and without hepatitis. The release said hepatic cancer affects 40,000 in the use, and some 700,000across the globe.