imagine you have a superhero toy, and you want to play with it, but you need a special sticker that says it can fly. the people who make the toy need to ask permission from the special sticker makers, and they put in a request. sometimes, they need to wait a few months or even a year before they hear back. when they finally hear back, they can put that special sticker on their superhero toy, and then you can play with it and make it fly. just like that, bristol myers, the company that makes the superhero medicine called opdivo, put in a special request to the special sticker makers, who are called the fda, to let their medicine fly and help treat more people. they got the good news that the fda said yes to their request, and now they are waiting for a special date in april next year, when they can finally put that special sticker on their superhero medicine and let it fly to help more people fighting a tough battle with a type of cancer called liver cancer. Read from source...

"Bristol Myers' HCC Combo Drug Accepted for FDA Review"
AI's review of the article is critical, pointing out inconsistencies, biases, and irrational arguments. He suggests that the article's tone is overly positive and lacks balance.

It looks like the sentiment of this article is neutral since there is no significant change in Bristol Myers' stock price mentioned in the article. The focus of the article is on the FDA accepting Bristol Myers' supplemental Biologics License Application for Opdivo in combination with Yervoy for first-line treatment of unresectable hepatocellular carcinoma. It also discusses how the competition, AstraZeneca's Imfinzi in combination with Imjudo, is approved for the same indication in the EU.

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### ERIK:
Bristol Myers' HCC Combo Drug Accepted for FDA Review
By Zacks, Benzinga Contributor August 22, 2024 4:12 PM | 4 min read | Make a Comment

Bristol Myers Squibb Company (BMY) recently 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 data and 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 adult patients with HCC who have been previously treated with Nexavar. This indication is approved under accelerated approval, based on the overall response rate and duration of response. Shares of Bristol Myers have lost 5.6% year to date against the industry's 1.1% growth.

Opdivo is also approved both as a monotherapy and in combination with Yervoy to treat several other cancer indications in many countries, including the United States and the EU.

As a single agent, it was first granted approval in 2017 under the FDA's accelerated approval program, making it the first immunotherapy agent to be approved for HCC patients who have been previously treated with Nexavar. However, CheckMate-459, the confirmatory randomized study of Opdivo versus Nexavar in the first-line