Bristol Myers Squibb (BMY) announced Friday that the European Medicines Agency’s Committee for Medicinal Products for Human Use or CHMP has recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adults with unresectable malignant pleural mesothelioma or MPM.
The European Commission, which has the authority to approve medicines for the European Union, will now review the CHMP recommendation. If approved, Opdivo plus Yervoy will be the first new treatment option authorized for European patients that has demonstrated improved survival in more than 15 years.
Malignant pleural mesothelioma is a rare but aggressive form of cancer that forms in the lining of the lungs. It is most frequently caused by exposure to asbestos.
Opdivo is a programmed death-1 or PD-1 immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response.
Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4).
The positive CHMP opinion is based on results from CheckMate -743, the first and only positive Phase 3 immunotherapy trial in first-line MPM. The trial met the primary endpoint of superior overall survival with Opdivo plus Yervoy versus chemotherapy (pemetrexed and cisplatin or carboplatin) in all randomized patients.
The company noted that the safety profile for Opdivo plus Yervoy in first-line MPM was manageable and consistent with previous studies of the combination in other tumor types.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries.
In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries.
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