Lilly’s CYRAMZA Gains Sixth FDA Approval

Eli Lilly and Co. received approval from the U.S. FDA for CYRAMZA (ramucirumab injection, 10 mg/mL solution), in combination with erlotinib, for the first-line treatment of 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 which CYRAMZA, a VEGF receptor 2 antagonist, in combination with erlotinib, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to placebo in combination with erlotinib (19.4 months compared to 12.4 months). The PFS treatment effect was consistent across exon 19 and exon 21 subgroups.

Fifty percent of people with NSCLC present with advanced or metastatic disease at diagnosis. The five-year survival rate for metastatic NSCLC patients is six percent. In the U.S., it is estimated that approximately 15 percent of people diagnosed with NSCLC have an EGFR mutation.