FDA has accepted Bristol Myers Squibb supplemental Biologics License Application (sBLA) to Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) for the first-line (1L) treatment of patients with unresectable hepatocellular carcinoma (HCC).
This decision was based on the positive results of the CheckMate -9DW trial for Opdivo®+Yervoy®, a step ahead for patients with HCC.
Dana Walker, M.D., VP at Bristol, acknowledged the FDA’s acceptance of the sBLA and highlighted the urgent need for new treatment options for HCC, noting that Opdivo®+Yervoy® has shown superior survival benefits.
She also expressed Bristol’s commitment to working with the FDA to potentially offer this new 1L treatment to HCC patients.
Opdivo®+Yervoy® has been previously approved as a second-line treatment for patients with advanced HCC.
The safety profile of Opdivo®+Yervoy® was consistent with previously reported data and was manageable with established protocols.
Source: Bristol Myers Squibb Receives U.S. Food and Drug Administration sBLA Acceptance for First-Line Treatment of Unresectable Hepatocellular Carcinoma
https://news.bms.com/news/corporate-financial/2024/Bristol-Myers-Squibb-Receives-U.S.-Food-and-Drug-Administration-sBLA-Acceptance-for-First-Line-Treatment-of-Unresectable-Hepatocellular-Carcinoma/default.aspx
