European Agency Recommends Approval of Opdivo Plus Yervoy for Mesothelioma
Survival outcomes for European mesothelioma patients are about to take a giant step forward now that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of a combination of Opdivo and Yervoy for the first line treatment of adults with the rare, asbestos-related form of cancer.
Recommendation Based on CheckMate-743 Trial Results
The combination of Opdivo (nivolumab) and Yervoy (ipilumumab) as treatment for malignant mesothelioma was investigated over the course of the European Phase 3 trial known as CheckMate-743. Researchers compared patients’ overall survival following treatment with the two immunotherapy treatments to that of patients treated with the current standard first-line chemotherapy treatment of pemetrexed and cisplatin or carboplatin.
The CheckMate-743 study included a total of 605 mesothelioma patients, 303 of whom received the immunotherapy treatment and 302 of whom received the chemotherapy treatment. The EMA is the European equivalent of the United States’ FDA, and the CHMP is the committee that expresses their opinions. The treatment itself is a product of Bristol Myers Squibb, whose vice president, thoracic cancers development lead Abderrahim Oukessou, M.D. said, “For more than 15 years, no new treatment options that can improve survival have been approved for malignant pleural mesothelioma, and today most patients only live for just over a year from the time of their diagnosis. Now, with the positive CHMP opinion for Opdivo plus Yervoy, we are one step closer to helping address the pressing unmet need for effective, proven therapies for this aggressive cancer. We look forward to potentially bringing the first immunotherapy combination that may offer a chance for a longer life to patients in the EU.”
Opdivo and Yervoy Already Approved in the United States
The recommendations from the EMA are an indicator that the drugs will likely receive approval for use in malignant mesothelioma patients in the European Union very soon. The drug combination has already been approved for use in untreated, unresectable malignant pleural mesothelioma in the United States and two other countries.
If someone you love has been diagnosed with malignant mesothelioma and you would like information about immunotherapy or any other resource available to you, contact the Patient Advocates at Mesothelioma.net today at 1-800-692-8608.
Written by Terri Oppenheimer
Learn more about and contact Terri
