Advisory Committee Votes in Favor of Eli Lilly’s Monoclonal Antibody

The FDA’s Oncologic Drugs Advisory Committee split on the benefit-risk profile for Eli Lilly’s monoclonal antibody Cyramza (ramucirumab), voting 6-5 in favor of the drug for patients with untreated metastatic EGFR-positive non-small cell lung cancer.

Committee members were more decisive in their vote on Steba’s Tookad (padeliporfin), shooting down the drug 2-13 for low-risk early stage prostate cancer.

Cyramza showed an improvement in progression-free survival for patients, it had an uncertain effect on their overall survival and showed increased toxicity with combination therapy in some, the FDA said in its analysis of the trial data.