European Journal of Cancer
Issue 4, 2010

By Helen Saul

FDA’s deliberations on erlotinib continue…

The US’ Food and Drug Administration (FDA) announced in January, 2010, that it has extended its review period for erlotinib (Tarceva) as first line maintenance therapy for advanced non-small cell lung cancer (NSCLC) by a further 90 days. This follows the submission of further data in support of the application by OSI Pharmaceuticals.

In December, 2009, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to one against approval of erlotinib for NSCLC patients whose cancer has not progressed following first-line treatment with platinum-based chemotherapy. However, the FDA is not bound by the recommendations of its advisory committee.

The ODAC recommendation was based on data from the company-sponsored phase III SATURN study, which showed a statistically significant improvement in both progression-free and overall survival with erlotinib compared to placebo.

OSI and Genentech have said that they will work closely with the FDA during the extended review period.