Ramucirumab Plus Erlotinib Approved by FDA in Metastatic NSCLC
Posted: Friday, June 5, 2020
On May 29, the U.S. Food and Drug Administration (FDA) approved the VEGFR2 antagonist ramucirumab (Cyramza) plus the tyrosine kinase inhibitor erlotinib for first-line treatment of metastatic non–small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 mutations. The recommended dose of ramucirumab for metastatic NSCLC in combination with erlotinib is 10 mg/kg every 2 weeks.
The FDA approval was based on the multinational, double-blind, multicenter RELAY study results. A total of 449 patients with previously untreated metastatic NSCLC whose tumors have EGFR exon 19 deletion or exon 21 substitution mutations were enrolled in the study. Patients were given an IV administration of either a 10-mg/kg dose of ramucirumab or a placebo for 2 weeks, in combination with a daily oral dose of 150 mg of erlotinib. Patients continued medication until disease progression or unacceptable toxicity.
Patients in the ramucirumab-plus-erlotinib arm had a progression-free survival of 19.4 months compared with 12.4 months in the placebo-plus-erlotinib arm (hazard ratio = 0.59; 95% confidence interval = 0.46–0.76; P < .0001). Also, the overall response rate was 76% versus 75%, respectively. Patients in the experimental arm had a longer duration of response of 18 months than the 11 months observed in the placebo arm.
Common adverse reactions observed in patients treated with ramucirumab and erlotinib included infections, hypertension, stomatitis, proteinuria, alopecia, epistaxis, and peripheral edema. The most common laboratory abnormalities were increased alanine aminotransferase levels, increased aspartate aminotransferase levels, anemia, thrombocytopenia, neutropenia, increased alkaline phosphatase levels, and hypokalemia.
For more prescribing information, visit accessdata.fda.gov.
