Bristol Myers Squibb (BMS) announced that the US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a potential first-line treatment for adult patients with unresectable hepatocellular carcinoma (HCC).
The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of 21 April 2025.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to get regulatory approval worldwide.
It is now approved in over 65 countries, including the US, the European Union (EU), Japan, and China.
In October 2015, the combination of Opdivo and Yervoy was the first immuno-oncology combo to be approved for metastatic melanoma and is now approved in more than 50 countries, including the US and the EU.
The filing was based on results from the Phase 3 randomised, open-label CheckMate-9DW study.
It randomised 668 patients with overall survival (OS) as the primary endpoint. Key secondary endpoints included objective response rate and time to symptom deterioration.
According to the findings, the combination of Opdivo and Yervoy led to a statistically significant and clinically meaningful improvement in OS compared to the investigator’s choice of lenvatinib or sorafenib.
While Opdivo plus Yervoy has been an established second-line treatment for advanced HCC, these findings support its potential as a new first-line treatment option.
The safety profile of the combination remained consistent with previously reported data, was manageable using established protocols, and no new safety signals were identified.
Bristol Myers Squibb gastrointestinal and genitourinary cancers global program lead and vice president Dana Walker said: “HCC is the most common form of liver cancer and is often diagnosed when surgery is no longer an option.
“With the number of individuals diagnosed with HCC in the United States increasing over the last decade, new treatment options are urgently needed.
“Opdivo plus Yervoy showed superior survival benefit compared to 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.”
In early 2022, BMS secured FDA approval for Opdivo with chemotherapy to treat resectable non-small cell lung cancer (NSCLC), regardless of PD-L1 status.
