Posted by Michael Wonder on 16 Dec 2019
CHMP issues positive opinion to expand Cyramza (ramucirumab) label to include results from RELAY study in patients with metastatic EGFR-mutated non-small cell lung cancer
13 December 2019 - Cyramza in combination with erlotinib recommended for approval in the EU for the first-line treatment of adult patients with metastatic non-small cell lung cancer with activating EGFR mutations.
Eli Lilly and Company announced today that the EMA's CHMP issued a positive opinion recommending a new indication and associated label update for Cyramza (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 CHMP opinion is based on the efficacy and safety demonstrated in the Phase 3 RELAY trial – a global randomised, double-blind, placebo-controlled trial evaluating Cyramza in combination with erlotinib, compared to placebo in combination with erlotinib, as a first-line treatment in patients with metastatic NSCLC whose tumours have activating EGFR mutations.
