FDA Approves Cyramza-Tarceva Combination for Frontline Treatment of Patients With Metastatic EGFR-Mutated NSCLC

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“The approval of this new firstline metastatic EGFR-mutated non-small cell lung cancer regimen … is an important milestone in the treatment of this disease,” said Dr. Edward Garon.

The Food and Drug Administration (FDA) has approved the combination of Cyramza (ramucirumab) and Tarceva (erlotinib) as a frontline treatment for patients with metastatic non—small cell lung cancer (NSCLC) whose tumors harbor either EGFR exon 19 deletions (Ex19del) or exon 21 (L858R) substitution mutations.

The agency based its approval on results from the phase 3 RELAY trial, which consisted of 449 patients with stage 4 NSCLC who harbored either an EGFR Ex19del or exon 21 L858R mutation and had an ECOG performance status of 0 to 1.

Study results demonstrated that the addition of Cyramza to Tarceva led to a 41% reduction in the risk of disease progression or death compared with Tarceva 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 —time from random assignment in a clinical trial to disease progression or death from any cause — in the Cyramza regimen vs. Tarceva alone was 19.4 months vs. 12.4 months, respectively.

“The approval of this new first-line metastatic EGFR-mutated non-small cell lung cancer regimen … is an important milestone in the treatment of this disease. It is wonderful that patients now have multiple options for initial therapy capable of delaying disease progression for considerably longer than erlotinib, which has been our traditional standard approach,” said Dr. Edward Garon, North America lead investigator of the RELAY trial and associate professor of medicine at the David Geffen School of Medicine at UCLA, in a press release.

The Cyramza labeling contains warnings and precautions about certain side effects that could be potentially severe and fatal, including:

  • hemorrhage and gastrointestinal hemorrhage;
  • gastrointestinal perforations;
  • impaired wound healing;
  • arterial thromboembolic events (ATEs);
  • infusion-related reactions, and
  • Posterior Reversible Encephalopathy Syndrome.

Median duration response in patients who received the combination was 18 months compared to 11.1 months in patients who received Tarceva alone.

Patients within the combination arm of the trial more frequently experienced grade 3 or higher side effects (72%) compared to patients who received Tarceva alone (54%).

“We're encouraged by Cyramza’s latest approval, which represents one step towards our goal of making EGFR-mutated non-small cell lung cancer into a manageable chronic disease," said Ivy Elkins, cofounder of patient advocacy group EGFR Resisters. “Each new treatment option gives hope to those living with this disease and provides oncologists with more options that may help slow the spread of this deadly cancer, which is an important goal for many patients.”