Cyramza wins narrow FDA adcomm vote

A vote of the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) on Eli Lilly’s (NYSE: LLY) Cyramza (ramucirumab) has narrowly come out in favor of using the drug in combination with erlotinib in a lung cancer indication.

The ODAC voted by six to five that the combination of Cyramza and erlotinib, which is marketed by Swiss pharma giant Roche (ROG: SIX) as Tarceva, demonstrated a favorable benefit/risk profile for patients with untreated metastatic EGFR-positive non-small cell lung cancer (NSCLC), based on the results of the positive Phase III RELAY study.

This does not make an FDA approval inevitable, even if the agency often does follow the recommendations made by these committees.