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Press release

July 26, 2021
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Bristol Myers Squibb withdraws liver cancer indication for nivolumab

Source:

Press release

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Bristol Myers Squibb in consultation with the FDA voluntarily withdrew the indication for nivolumab as monotherapy for patients with hepatocellular carcinoma previously treated with sorafenib.

The company did so after the agency’s evaluation of accelerated approvals for checkpoint inhibitors that did not meet post-marketing requirements.

The evaluation process included a special Oncologic Drugs Advisory Committee (ODAC) meeting this spring, as well as follow-up discussion with the FDA. ODAC members voted 5-4 against maintaining the nivolumab indication.

“We are disappointed by the position the advisory committee and the FDA have taken regarding the continued approval of Opdivo monotherapy as a treatment for HCC [after] sorafenib,” Jonathan Cheng, senior vice president and head of oncology development for Bristol Myers Squibb, said in a company-issued press release. “HCC is a complex and challenging disease and, for patients who are initially treated with sorafenib and either cannot tolerate treatment or whose disease progresses, immunotherapy is an important treatment option.

“For the past three-and-a-half years, Opdivo monotherapy has been an important option that physicians have relied on to address this need and is currently the most commonly used therapy in the post-sorafenib setting,” Cheng added. “Opdivo helped usher in an entirely new way to treat patients with this disease. We continue to support the FDA’s accelerated approval program, which has been integral to enabling people with difficult to treat cancers to gain access to certain safe and effective new therapies sooner.”

The FDA granted accelerated approval to nivolumab (Opdivo), a PD-1 immune checkpoint inhibitor, for the HCC indication in 2017 based on tumor responses observed in the phase 1/phase 2 CheckMate -040 trial.

The confirmatory randomized CheckMate -459 trial compared nivolumab with sorafenib (Nexavar, Bayer) as first-line treatment. Results showed no statistically significant benefit with nivolumab for OS, the study’s primary endpoint.

Bristol Myers Squibb’s decision does not affect the approval of nivolumab in other settings, including an indication that authorizes its use in combination with the anti-CTLA-4 antibody ipilimumab (Yervoy, Bristol Myers Squibb) for patients with HCC who progressed on or were intolerant to sorafenib.