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Lilly's CYRAMZA® (ramucirumab) Receives FDA Approval as First-Line Treatment for Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

Published: 2020-05-30 01:07:00 ET
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CYRAMZA, in combination with erlotinib, now approved for the treatment of people with untreated metastatic non-small cell lung cancer (NSCLC) with certain activating EGFR mutations, based on the positive global Phase 3 RELAY study

CYRAMZA regimen reduced the risk of disease progression or death by 41 percent compared to erlotinib in this patient population

INDIANAPOLIS, May 29, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (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 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