Opdivo plus Yervov and chemo recommended for EU approval

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of platinum-based chemotherapy for the first-line treatment of metastatic non-small cell lung cancer (NSCLC).

The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.

“This positive CHMP opinion reflects the potential for Opdivo plus Yervoy with two cycles of chemotherapy to offer the chance for a longer life to patients across subgroups of metastatic NSCLC, a devastating cancer where unmet needs still exist,” said Abderrahim Oukessou, Vice President, Thoracic Cancers Development Lead, Bristol Myers Squibb.

“We look forward to the EC’s decision and hope to soon introduce this innovative, dual immunotherapy approach to patients across the EU who may benefit.”

The CHMP adopted the positive opinion based on results from the Phase 3 CheckMate -9LA trial, which met the primary endpoint of superior overall survival.

The safety profile of Opdivo plus Yervoy and two cycles of chemotherapy was reflective of the known safety profiles of the immunotherapy and chemotherapy components in first-line NSCLC.

To date, the combination of Opdivo plus Yervoy with two cycles of chemotherapy has been approved in nine countries, including the US, for the first-line treatment of patients with metastatic NSCLC.

Approval by the EC would mark the third indication for Opdivo plus Yervoy­based combinations in the EU, following previous approvals in metastatic melanoma and advanced renal cell carcinoma.

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