Eli Lilly and Company have announced that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration positively endorsed Alimta® (pemetrexed), an antifolate, for accelerated approval in the second-line treatment of non-small cell lung cancer.
"The committee's unanimous recommendation is a major step forward for patients being treated for non-small cell lung cancer in the second-line setting," said Paolo Paoletti, M.D., vice president of oncology clinical research at Lilly. "Study data show that Alimta's effectiveness is comparable to Taxotere, is conveniently administered and is better tolerated."
The ODAC recommendation supports a possible FDA approval of Alimta as a single-agent therapy for patients with locally advanced or metastatic non-small cell lung cancer after receiving prior chemotherapy. The committee based its opinion upon one of the largest Phase III studies to date in the second-line setting in which Alimta was compared head-to-head to Taxotere® (docetaxel).
The Phase III study showed: