Dr. Santos on the FDA Approval of Ramucirumab/Erlotinib in EGFR-Mutant NSCLC

Edgardo S. Santos, MD, FACP, FCCP, a medical oncologist of internal medicine at Boca Raton Regional Hospital, discusses the FDA approval of the combination of ramucirumab (Cyramza) and erlotinib (Tarceva) for the frontline treatment of patients with metastatic non—small cell lung cancer (NSCLC) whose tumors harbor EGFR exon 19 deletions or exon 21 substitution mutations.

The May 30, 2020 approval follows a 6 to 5 recommendation vote from the FDA's Oncologic Drugs Advisory Committee and is based on findings from the phase 3 RELAY trial. In the study, results showed that the addition of ramucirumab to erlotinib led to a 41% reduction in the risk of disease progression or death compared with erlotinib alone in the first-line treatment of patients with EGFR-mutated NSCLC.

At a median follow-up of 20.7 months, the investigator-assessed median progression-free survival (PFS) with the ramucirumab regimen versus erlotinib alone was 19.4 months (95% CI, 15.4-21.6) versus 12.4 months (95% CI, 11.0-13.5), respectively (HR, 0.59; 95% CI, 0.46-0.76; P <.0001). The approval is not likely to impact the use of osimertinib, as the third-generation EGFR TKI is the preferred agent in this setting, says Santos. However, the combination could be an option for patients with exon 21 substitution mutations, concludes Santos.