FDA Accepts sBLA for Nivo/Ipi as First-Line Treatment of Unresectable HCC

The US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for nivolumab (Opdivo) plus ipilimumab (Yervoy) as a potential first-line treatment for adult patients with unresectable hepatocellular carcinoma (HCC).

The decision to accept the sBLA is based on the encouraging results of the phase 3 CheckMate-9DW study, which demonstrated that the immunotherapy combination offers a statistically significant improvement in overall survival, higher response rates, and durable responses compared with investigator’s choice of lenvatinib or sorafenib. Additionally, investigators found that the safety profile for the combination was consistent with previously reported data, and no new safety signals were identified.

“With the number of individuals diagnosed with HCC in the United States increasing over the last decade, new treatment options are urgently needed,” said Dana Walker, MD, MSCE, vice president and global program lead, gastrointestinal and genitourinary cancers, at Bristol Myers Squibb, in a press release. “Nivolumab plus ipilimumab showed superior survival benefit compared with other available treatment options, and we look forward to working with the FDA to advance our application to potentially bring a new first-line treatment option to patients.”

While ipilimumab plus nivolumab is considered a safe and effective second-line treatment for patients with advanced HCC, results of the CheckMate-9DW study suggest the combination’s potential as a new treatment option in the first-line setting.

The FDA has assigned a Prescription Drug User Fee Act goal date of April 21, 2025.