Europe is poised to see a new first-line therapy for mesothelioma after getting the green light from a medical review agency.
A division of the European Medicines Agency (EMA) — which is equivalent to the FDA — has signed off on the use of a two-drug combo to treat malignant pleural mesothelioma in the European Union, an important first step toward approval, according to an April 23 release from Bristol Myers Squibb.
The pharmaceutical company makes both drugs in the cocktail: the immunotherapy drug nivolumab (branded as Opdivo) and another immunotherapy drug, ipilimumab (which is branded as Yervoy).
Pathway to Approval
According to the release, the EMA’s Committee for Medicinal Products for Human Use recommended the combination product be approved as an initial treatment option for mesothelioma patients. The committee’s recommendation now goes to the European Commission: the largest institution in the E.U. and the final stop for all drug approvals.
The commission generally goes along with committee recommendations, though not always.
If the combo therapy wins approval, it will be the first new mesothelioma treatment with a demonstrable improvement in survival time to be authorized in Europe in more than 15 years, according to the release.
The EMA committee’s recommendation is based on the success of CheckMate 743, a Phase III study that tested the immunotherapy combo as a first-line treatment for mesothelioma. The study showed that patients taking the combo drug lived on average four months longer, with a median overall survival time of 18 months versus 14 months with chemotherapy. The study was funded by Bristol Myers Squibb.
“With the positive [committee] 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,” said Abderrahim Oukessou, who heads up Bristol Myers Squibb’s thoracic cancers drug development unit. “We look forward to potentially bringing the first immunotherapy combination that may offer a chance for a longer life to patients in the E.U.”
The combination drug has already been approved for unresectable mesothelioma in three countries, including the U.S., according to the release.