FDA Approves Combination Immunotherapy Treatment for Mesothelioma
For the first time in sixteen years, the U.S. Food and Drug Administration (FDA) has given its approval for a new, systemic treatment for malignant mesothelioma. The remarkable move came after the use of a combination of nivolumab (Opdivo) and ipilimumab (Yervoy) treatments provided a more than twenty percent improvement in overall survival for patients who were not eligible for surgery.
Opdivo and Yervoy Extend Overall Survival
Though there have been numerous reports of success in the use of the two monoclonal antibodies against malignant pleural mesothelioma, the FDA approval of the combination still caught the medical world by surprise.
The two medications work by enhancing T-cell functions and helping them decrease the rate of malignant mesothelioma tumor growth. In a randomized, open-label trial of over 600 patients diagnosed with unresectable, untreated malignant pleural mesothelioma, patients provided with IV infusions of nivolumab every two weeks and of ipilimumab every 6 weeks lived a median of four months longer than those who had been treated with a combination of platinum chemotherapy drugs.
Four More Months of Survival for Malignant Pleural Mesothelioma Patients
In the life of a patient diagnosed with malignant pleural mesothelioma, four months is extremely significant. Speaking of the agency’s decision to provide a mesothelioma drug with approval for the first time in sixteen years, Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research said “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. In 2004, FDA approved pemetrexed in combination with cisplatin for this indication, and now patients have an important, additional treatment option after more than a decade with only one FDA-approved drug regimen.”
For patients diagnosed with malignant pleural mesothelioma and not eligible for surgical removal of their tumors, the combination treatment offers new hope for a bit more time with family and friends. Though the treatment does have adverse side effects, they are relatively mild when compared to chemotherapy, and include fatigue, musculoskeletal pain, rash, diarrhea, dyspnea, nausea, decreased appetite, cough, and pruritis. Ipilimumab is known to cause immune-mediated side effects, including inflammation of healthy organs such as the lungs, colon, liver, endocrine glands, and kidneys.
For more information on facilities offering this innovative medical treatment, contact the Patient Advocates at Mesothelioma.net today at 1-800-692-8608.
Written by Terri Oppenheimer
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