NEW YORK – The US Food and Drug Administration has approved Eli Lilly's ramucirumab (Cyramza) in combination with erlotinib (Genentech's Tarceva) for the first-line treatment of EGFR-mutated, metastatic non-small cell lung cancer.
According to Lilly, this is the first time the FDA has approved an anti-VEGFR/EGFR inhibitor combination for this group of patients. The approval was based on the results of the Phase III RELAY trial, which compared ramucirumab-erlotinib against erlotinib and showed that patients treated with the combination had a median progression-free survival of 19.4 months compared to 12.4 months for those on erlotinib.
Earlier this year, the FDA's Oncologic Drugs Advisory Committee narrowly voted — six for and five against — in favor of approving the combination. The committee had requested survival data from RELAY, which won't be mature until 2023. However, at the committee's request, Lilly statistically projected that overall survival would be 58 months for ramucirumab-erlotinib versus 52 months for erlotinib.Â
The FDA-approved label for ramucirumab warns patients about the risk of gastrointestinal hemorrhage, infusion reactions, and arterial thrombotic events that can sometimes be fatal. The drug should be permanently discontinued in patients who experience severe bleeding.
The European Union has approved ramucirumab-erlotinib for this same indication based on the RELAY results, and Lilly has also submitted the data for approval in Japan where regulators are expected to issue a decision later this year.
Erlotinib is a first-generation EGFR tyrosine kinase inhibitor for the treatment of NSCLC patients with EGFR exon 19 deletions or exon 21 (L858R) mutations. Ramucirumab was also previously approved by the FDA in combination with docetaxel as a treatment for metastatic NSCLC patients who have been on platinum-based chemotherapy.