FDA rejects Traceva for earlier use in lung cancer patients

Wall Street Journal reported on Dec 16 that a Food and Drug Administration panel rejected earlier use of Tarceva in patients with advanced lung cancer.

Tarceva, co-marketed by OSI Pharmaceuticals Inc. (OSIP) and Roche's (ROG.VX) Genentech unit has already obtained FDA approval for use in patients with non-small cell lung cancer after chemotherapy fails to stop the spread of the disease.

The companies filed a petition to the FDA for use of Tarceva as a maintenance treatment in lung cancer patients who have completed chemotherapy.

A study showed that Tarceva offers some benefits. 

Of 889 patients with advanced lung cancer who had finished four cycles of chemo and had their disease under control, those who were given Tarceva had a median progression-free survival of 12.3 weeks compared to 11.1 weeks for those who took a placebo.

By Jimmy Downs