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Lilly : CHMP Issues Positive Opinion To Expand Cyramza Label

Eli Lilly and Co. (LLY) said that the European Medicines Agency's or EMA Committee for Medicinal Products for Human Use or CHMP issued a positive opinion recommending a new indication and associated label update for Cyramza or ramucirumab.

The Committee agreed that the label should include an indication for Cyramza in combination with erlotinib for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.

The CHMP positive opinion is now referred for final action to the European Commission, which grants approval in the European Union.

The positive opinion was based on Phase 3 RELAY study, which showed significant improvement in progression-free survival.

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