It has been reported that Roche and OSI Pharmaceuticals have been granted permission by the FDA to use the drug Tarceva as a maintenance treatment for non-small cell lung cancer.

This decision comes beside the earlier negative reports given by an advisory panel. The panel voted 12-1 against the approval of the drug.

It is reported that Tarceva will now have to vie against Alimta in the maintenance setting.

Tarceva has already been given approval the FDA and EMA (European Medicines Agency) for the second- and third-line treatment of advanced non-small cell lung cancer (NSCLC).

This latest approval implies that Tarceva will be employed as maintenance therapy for patients with locally advanced or metastasized NSCLC. It can be used on people whose cancer has not advanced. It can be used after four cycles of platinum-based first-line chemotherapy, for both squamous and non-squamous histology.

It has been reported that the approval is founded on the pivotal Phase III Saturn trial.

The Saturn trial, took into consideration 889 patients, who did not show any evidence of disease progression after four cycles of chemotherapy. These patients were arbitrarily given either 150mg of Tarceva per day
(438 patients) or placebo (451 patients) until disease progression.

It was seen that patients treated with Tarceva had a 41% improvement in progression-free survival compared to the placebo.