Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) and granted Breakthrough Therapy Designation for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib. The FDA granted the application Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of March 10, 2020.
"The FDA’s acceptance of our application for Opdivo plus Yervoy represents important progress for patients with liver cancer in the United States, where hepatocellular carcinoma is the fastest rising cause of cancer-related death," said Ian M. Waxman, M.D., development lead, Gastrointestinal Cancers, Bristol-Myers Squibb. "Despite recent advances, hepatocellular carcinoma remains a difficult-to-treat cancer and patients are in need of additional effective treatment options. We look forward to working with the FDA to bring the potential of a dual Immuno-Oncology therapy to these patients for the first time."
This application is based on data from the Opdivo plus Yervoy cohort of the Phase 1/2 CheckMate -040 study evaluating the Immuno-Oncology combination in patients with advanced HCC previously treated with sorafenib. Data from this study were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.
The FDA’s Breakthrough Therapy Designation is a process intended to enable timely patient access by expediting the development and review of medicines for serious conditions where preliminary clinical evidence indicates a substantial improvement over available therapies on one or more clinically significant endpoints.
About CheckMate -040
CheckMate -040 (NCT01658878) is an ongoing Phase 1/2, open-label, multi-cohort study investigating Opdivo or Opdivo-based combinations in patients with advanced HCC with and without chronic viral hepatitis who are naïve, intolerant to or who have progressed during sorafenib therapy.
The Opdivo plus Yervoy cohort of CheckMate -040 is evaluating the safety and efficacy of the combination in patients with previously treated advanced HCC. Primary endpoints include safety and tolerability, and objective response rate based on investigator assessment using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Secondary endpoints include disease control rate, duration of response, overall survival, time to response, time to progression and progression-free survival.
About Hepatocellular Carcinoma
Liver cancer is the fourth most frequent cause of cancer death worldwide and HCC, the most common type of liver cancer, is the fastest rising cause of cancer-related death in the United States. Although the FDA has approved several new agents in the second-line setting in recent years, HCC is often diagnosed in the advanced stage and has a poor prognosis, underscoring the need for new treatment options. While most cases of HCC are caused by hepatitis B virus (HBV) or hepatitis C virus (HCV) infections, metabolic syndrome and nonalcoholic steatohepatitis (NASH) are rising in prevalence and expected to contribute to increased rates of HCC.
Bristol-Myers Squibb: Advancing Oncology Research
At Bristol-Myers Squibb, patients are at the center of everything we do. The focus of our research is to increase quality, long-term survival for patients and make cure a possibility. Through a unique multidisciplinary approach powered by translational science, we harness our deep scientific experience in oncology and Immuno-Oncology (I-O) research to identify novel treatments tailored to individual patient needs. Our researchers are developing a diverse, purposefully built pipeline designed to target different immune system pathways and address the complex and specific interactions between the tumor, its microenvironment and the immune system. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines, like I-O, a reality for patients.
About Opdivo
Opdivo...
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