Bristol Myers pulls Opdivo for use in liver cancer amid broader FDA scrutiny of speedy approvals

Bristol Myers Squibb

Bristol Myers Squibb


Bristol Myers Squibb is withdrawing its blockbuster cancer immunotherapy from use in liver cancer, the latest drug pulled from the market amid broader FDA scrutiny of medicines that were given accelerated approval.

The pullback of the drug, Opdivo, follows an April FDA advisory committee meeting that scrutinized whether certain cancer drugs have met the requirements needed to retain approval status. The committee voted 5 to 4 against recommending against Opdivo keeping its approval. While the FDA has the authority to remove a drug from the market if it fails to demonstrate efficacy, Bristol said its withdrawal of the drug from use in liver cancer is voluntary and the decision was made in consultation with the regulator.

Accelerated approvals are decisions based on a thinner body of evidence than is required for a standard drug review. These speedier decisions get a drug to patients more quickly, but they also require drug companies to conduct additional post-marketing studies to confirm the drug’s benefit.

Opdivo is an antibody designed to block PD-1, a protein found on the surface of immune cells that has the effect of stopping these cells from targeting tumors. Blocking this protein frees the immune cell go forth and tackle a patient’s cancer. Opdivo won its first accelerated approval, for melanoma, in 2014. The drug has since gone on to rack up additional accelerated approvals for other cancers. The drug accounted for more than $6.9 billion in revenue last year, according to Bristol’s 2020 annual report.

In 2017, the FDA awarded Opdivo accelerated approval for liver cancer patients whose disease did not respond to earlier treatment with sorafenib, the standard first-line treatment for this type of cancer. That regulatory decision made the drug the first immunotherapy approved for this indication. However, the confirmatory study failed to show statistically significant improvement compared to sorafenib.

Liver cancer patients do have another treatment option, and it’s one that’s offered by Bristol. The company said that Opdivo combined with another Bristol immunotherapy, Yervoy, can be used to treat liver cancer patients whose disease has progressed. The combination can also be used for treating patients who can’t tolerate sorafenib.

Liver cancer is not the first indication from which Bristol has withdrawn Opdivo’s use. Late last year, the New York-based pharmaceutical giant said it would withdraw the drug from use in the U.S. in patients with small cell lung cancer. That decision followed drug’s failure to meet the main goal of improving overall survival in two confirmatory studies.

Other pharmaceutical companies have been pulling back the use of their drugs amid FDA scrutiny of confirmatory studies. In February, AstraZeneca said its blockbuster seller Imfinzi would be withdrawn from use in the U.S. in bladder cancer following the drug’s failure in a confirmatory study. Two weeks later, Roche announced it would withdraw U.S. use of its blockbuster drug Tecentriq in bladder cancer following the failure of that drug’s confirmatory study.

Photo: Jeremy Moeller, Getty Images