FDA approves drug combo treatment for mesothelioma
A drug combo treatment for malignant pleural mesothelioma, which could no longer be removed through surgery, was approved by the FDA.
Exposure to asbestos fibers can lead to mesothelioma, a type of cancer that results from inhalation of these particles. Fortunately, the U.S. Food and Drug Administration (FDA) has approved a drug treatment combo for the disease.
The FDA revealed on Friday that Opdivo (nivolumab) combined with Yervoy (ipilimumab) was approved for treating adults who suffer from malignant pleural mesothelioma, which could no longer be removed through surgery. It is a major feat for this kind of cancer as it is the first drug regimen approved for the disease in 16 years. It is also the second systemic therapy approved by the agency for the disease. Bristol-Myers Squibb Company was the one that got the approval from the FDA.
Richard Pazdur, director of the Oncology Center of Excellence of FDA said that the approval of the drug combo demonstrates an improvement in the survival of those suffering from the disease. He said that in 2004, the FDA gave its nod to using pemetrexed plus cisplatin in treating mesothelioma. The approval of nivolumab and ipilimumab gives patients an additional treatment option.
Every year, approximately 20,000 Americans are diagnosed with malignant pleural mesothelioma (MPM). This is a life-threatening form of lung cancer caused by the inhalation of asbestos fibers. The disease usually affects the lining of the lungs. At the time that patients receive a diagnosis, many of them would already have a tumour, which cannot be removed through a surgical procedure. The FDA noted that for so long a time, the survival rates using the existing therapy have been generally poor. With the combination of Opdivo and Yervoy, which are both monoclonal antibodies, it enhances the T-cell function and decreases tumour growth.
To evaluate the drug combo, a randomised open-label trial was conducted on 605 patients who previously had untreated MPM that can no longer be removed by surgery. The patients received Opdivo every two weeks through intravenous infusion, along with Yervoy every six weeks. This was continuously done for two years.
The researchers observed that patients who received the drug combo treatment survived an average of 18.1 months. On the other hand, those who underwent chemotherapy survived an average of 14.1 months.
Some of the common side effects observed in patients who received the drug combo treatment include rash, diarrhea, fatigue, musculoskeletal pain, nausea, cough, and decreased appetite.
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