Bristol Myers Squibb Pulls Immunotherapy Opdivo from US Market
The move follows the FDA Advisory Committee’s evaluation of accelerated approvals for checkpoint inhibitors that did not meet their post-marketing requirements.
Source: Getty Images
By - Bristol Myers Squibb recently announced its voluntarily withdrawal of the indication for Opdivo, its single-agent immunotherapy for patients with hepatocellular carcinoma (HCC), from the US market.
The company made the decision following the FDA Advisory Committee’s industry-wide evaluation of accelerated approvals for checkpoint inhibitors that have not met their post-marketing requirements showing real benefit.
The evaluation included a meeting of the Oncologic Drugs Advisory Committee in April and a follow-up discussion with FDA.
“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 post-sorafenib,” Jonathan Cheng, senior vice president and head of oncology development at Bristol Myers Squibb, said in the announcement.
“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 continued.
FDA granted accelerated approval to Opdivo in 2017, making it the first immunotherapy agent approved for use in this setting.
The agency based its approval on a 154-patient subgroup of CheckMate -040, a multicenter, open-label trial of patients with HCC and Child-Pugh A cirrhosis who progressed on or were intolerant to sorafenib.
In the trial, 91 percent of responders had responses lasting six months or longer and 55 percent had responses lasting 12 months or longer.
Opdivo in combination with Yervoy is a useful treatment option in the HCC setting and addresses significant unmet needs for HCC patients who have progressed on or were intolerant to sorafenib.
FDA’s recommended dosing regimen for Opdivo and Yervoy for HCC patients who have been previously treated with sorafenib is Opdivo 1 milligram/kilogram every three weeks, with Yervoy 3 milligrams/kilogram intravenously on the same day for four doses.
This treatment regimen is followed by Opdivo monotherapy 240 milligrams every two weeks or 480 milligrams every four weeks until disease progression or unacceptable toxicity.
Opdivo and Opdivo-based combinations have significant benefits across many cancer types, including non-small cell lung cancer, bladder cancer, and esophageal, gastric, and gastroesophageal junction cancers.
FDA approved Opdivo in April, making it the first immunotherapy for initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.
The agency based its approval on the randomized, multicenter trial of 1,581 patients with previously untreated gastric cancer.
In the trial, 789 patients who received Opdivo in combination with chemotherapy lived longer than the 792 patients who received chemotherapy alone.
Specifically, the median survival was 13.8 months for patients who received Opdivo plus chemotherapy, compared to 11.6 months for patients who received chemotherapy alone.
