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 3 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
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