Bristol-Myers Squibb is quit Its blockbuster cancer immunotherapy is used for liver cancer, which is the latest drug withdrawn from the market following a broader review of accelerated approval drugs by the FDA.
The withdrawal of the drug Opdivo follows the April FDA Advisory Committee meeting, which reviewed whether certain anti-cancer drugs meet the requirements needed to maintain approval status. The committee voted 5 to 4 against and recommended that Opdivo retain its approval. Although the FDA has the right to withdraw the drug from the market if it fails to prove its effectiveness, Bristol stated that its withdrawal of the drug for liver cancer is voluntary, and the decision was made after consultation with regulatory agencies .
Accelerated approval is based on decisions that are thinner than the evidence required for standard drug reviews. These faster decisions get the drug into the hands of patients faster, but they also require pharmaceutical companies to conduct additional post-market research to confirm the benefits of the drug.
Opdivo is an antibody designed to block PD-1. PD-1 is a protein on the surface of immune cells that prevents these cells from targeting tumors. Blocking this protein can release immune cells and treat the patient’s cancer. Opdivo first received accelerated approval for melanoma in 2014. Since then, the drug has continued to receive additional accelerated approvals for other cancers. According to Bristol’s 2020 annual report, the drug’s revenue last year exceeded US$6.9 billion.
In 2017, the FDA granted Opdivo accelerated approval for patients with liver cancer who had failed early treatment with sorafenib (the standard first-line treatment for this type of cancer). This regulatory decision makes the drug the first immunotherapy approved for this indication. However, the confirmatory study failed to show a statistically significant improvement compared to sorafenib.
Liver cancer patients do have another treatment option, which is provided by Bristol. The company said that Opdivo combined with Yervoy, another Bristol immunotherapy, can be used to treat liver cancer patients whose disease has progressed. The combination can also be used to treat patients who cannot tolerate sorafenib.
Liver cancer is not the first indication for Bristol to withdraw Opdivo.At the end of last year, the New York-based pharmaceutical giant said it would extract The drug is used in the United States for patients with small cell lung cancer. The decision was made after the drug failed to achieve the main goal of improving overall survival in two confirmatory studies.
During the FDA’s review of confirmatory studies, other pharmaceutical companies have been withdrawing the use of their drugs. In February, AstraZeneca said its blockbuster seller Imfinzi will stop using it to treat bladder cancer in the United States After the drug failed in a confirmatory study. Two weeks later, Roche announces that it will withdraw its blockbuster drug Tecentriq to treat bladder cancer in the U.S. After the confirmatory study of the drug failed.
Photo: Jeremy Moeller, Getty Images
