FDA approves Cyramza + erlotinib for first-line treatment of metastatic NSCLC with EGFR exon 19 deletions or exon 21 (L858R) mutations.- Eli Lilly

Eli Lilly and Company announced that the FDA has approved Cyramza (ramucirumab injection, 10 mg/mL solution), in combination with erlotinib, for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. With this approval, Cyramza has now received six FDA approvals to treat certain types of lung, liver, stomach and colorectal cancers. Cyramza plus erlotinib is the first and only FDA-approved anti-VEGFR/EGFR TKI combination therapy for metastatic EGFR-mutated NSCLC.

This approval is based on the efficacy and safety from the global, randomized, placebo-controlled Phase III RELAY trial. In the RELAY study, Cyramza a VEGF receptor 2 antagonist, in combination with erlotinib, a globally approved EGFR-targeting tyrosine kinase inhibitor (TKI), demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) – the time patients lived without their cancer growing or spreading after starting treatment – compared to placebo in combination with erlotinib [19.4 months in the Cyramza-containing arm compared to 12.4 months in the placebo-containing arm (HR=0.59; 95% CI, 0.46, 0.76; p<0.0001)]. The PFS treatment effect was consistent across exon 19 and exon 21 subgroups. The overall safety profile observed in the RELAY study was consistent with that of its individual components. RELAY is the second positive Phase III trial of Cyramza in metastatic NSCLC. The first was REVEL, which supported the approval of Cyramza plus docetaxel as a treatment for people with metastatic NSCLC whose cancer has progressed after prior platinum-based chemotherapy.