Bristol Myers (NYSE: BMY) announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for the immunotherapy drug, Opdivo (nivolumab), in combination with Yervoy (ipilimumab).
The sBLA seeks approval of Opdivo plus Yervoy as a potential first-line treatment option for adult patients with unresectable hepatocellular carcinoma. A final decision from the regulatory body in the United States is expected on Apr 21, 2025.
Bristol Myers' application is based on results from the late-stage CheckMate-9DW study.Results from the phase III CheckMate -9DW study showed that Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in overall survival compared with the investigator's choice of Lenvima or Nexavar. The combination therapy also demonstrated a safety profile consistent with previously reported dataand was manageable with established protocols. Additionally, no new safety signals were identified.
Per BMY, liver cancer is the third most frequent cause of cancer death worldwide and HCC is the most common type of primary liver cancer. HCC accounts for 75-85% of all liver cancers. It is mostly detected at a very advanced stage, wherein effective treatment options are limited and usually associated with poor outcomes.
Please note that Opdivo, in combination with Yervoy, is already indicated in the United States for the treatment of ...
