FDA Approves Opdivo, Yervoy Drug Combo To Treat Mesothelioma
Federal drug regulators have approved a combination of two cancer medications, Opdivo and Yervoy, for the treatment of mesothelioma, despite some previous concerns about the potential side effects.
In a press release issued on October 2, the FDA announced the approval of the Opdivo/Yervoy drug combination as a first line of treatment for adults with malignant pleural mesothelioma, which is a rare and particularly deadly form of cancer associated with exposure to asbestos particles.
According to the agency, it is the first drug regimen approved for mesothelioma patients in 16 years. Mesothelioma cancer is often at a particularly advanced stage by the time it is diagnosed, often coming decades after exposure to asbestos fibers. Cases have been linked to both direct exposure among individuals who worked with asbestos products decades ago, or family members of individuals who worked in certain industries, where the fibers may have been carried home in their parents hair or on their clothes.
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Opdivo (nivolumab) and Yervoy (ipilimumab) are members of a class of cancer drugs known as Immune checkpoint inhibitors (ICIs). Both are manufactured and sold by Bristol-Myers Squibb. They started out as a treatment of melanoma skin cancer, and have sense expanded to treatment for a number of other types of cancer. They are often combined together for treatment.
According to the FDA, the drug combination was tested during a randomized, open-label trial involving 605 patients with previously untreated malignant pleural mesothelioma. During the trial, patients were given intravenous infusions of Yervoy every six weeks, and infusions of Opdivo every two weeks. The findings indicate those given the combination survived a median of 18.1 months, compared to those who underwent chemotherapy, who only survived for 14.1 months.
“Today’s approval of nivolumab plus ipilimumab provides a new treatment that has demonstrated an improvement in overall survival for patients with malignant pleural mesothelioma,” Dr. Richard Pazdur, director of the FDA’s Oncology Center of Exellence, and acting director of the Office of Oncologic Diseases in the FDA’s Centr for Drug Evaluation and Research. “In 2004, FDA approved pemetrexed in combination with cisplatin for this indication, and now patients now have an important, additional treatment option after more than a decade with only one FDA-approved drug regimen.”
However, some studies have raised questions about how well cancer patients tolerate the powerful drug combo.
A study published in JAMA Oncology in August 2017 warned that as many as nine out of 10 patients given the drug combo suffered significant immune-related adverse events. However, in that study the patients were given a dose of both drugs every three weeks. Only 39% of those patients were able to tolerate four doses.
In November 2016, a similar study was published in the New England Journal of Medicine, which found that a combination of Opdivo and Yervoy may increase the risk of a life-threatening heart condition. In that study, researchers warned that two patients died after developing myositis with rhabdomyolysis, as well as electrical instability in the heart. They also found T-cell and macrophage infiltrates in the hearts of the patients.
A 2016 study by Johns Hopkins researchers also linked Opdivo and Yervoy to immune-related adverse events, which could manifest as inflammatory arthritis and sicca syndrome.
Other types of immune responses have been linked to the drugs, which strengthens the chances that the drugs can cause arthritis as well. During the original clinical trials for Yervoy and Opdivo, increased risks were detected for inflammatory bowel diseases, lung inflammation, and other side effects that are considered immune-related.
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