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FDA Approves Bristol Myers Squibb's Liver Cancer Drug Combo

By Mark Prvulovic - Updated Mar 11, 2020 at 5:03PM

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The drug company will still need to perform confirmatory studies, however.

Bristol Myers Squibb (BMY -0.21%) announced on Wednesday that its liver cancer drug combo had officially received approval from the U.S. Food and Drug Administration. The Opdivo (nivolumab) plus Yervoy (ipilimumab) treatment will be used in patients with hepatocellular carcinoma (HCC), one of the most aggressive and common types of liver cancer.

The FDA gave the thumbs up to the drug combo based on the results of a phase 1/2 open-label clinical study called Checkmate-040. In this trial, patients who had HCC but were resistant to other treatments -- mainly Nexavar, which is produced by Bayer -- were tested with Opdiov-Yervoy to see if there would be any improvements.

A female scientist in a lab looking through a microscope.

Image source: Getty Images.

While a significant portion of patients responded to the drug -- around 33% -- as many as 59% of patients ended up experiencing adverse reactions, the most common of which included rashes, pruritus (itching of the skin), diarrhea, and nausea. Since the Opdivo-Yervoy drug combo had been under accelerated review status, Bristol Myers will still be required to run further confirmatory trials to test the safety and efficacy of the treatment.

Further details

The FDA approval was a well-timed piece of good news for the pharmaceutical giant, which disappointed investors Monday when it reported that a combination multiple myeloma treatment had failed in a phase 3 trial. Results showed that adding Empliciti to a combo of  Revlimid and dexamethasone provided no statistically meaningful improvement over Revlimid and dexamethasone alone.

There are a couple of other expected FDA announcements for Bristol Myers investors to look forward to. Those include a pending decision regarding the company's multiple sclerosis drug, Ozanimud, as well as one for its myelodysplastic syndromes treatment, Reblozyl.

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