OSI and Genentech plan label-extension application with FDA to mirror Roche’s EU filing made last year.

The independent data monitoring committee for a Phase III study evaluating Roche’s Tarceva (erlotinib) in a population of patients with newly diagnosed EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC) has recommended stopping the trial early because it met its primary endpoint. The Eurtac study compared the EGFR inhibitor Tarceva with platinum-based chemotherapy, specifically in Western patients with NSCLC that expressed EGFR-activating mutations. It found that comapred with the chemo regimen, Tarceva therapy significantly extended progression-free survival.

Tarceva is being developed and commercialized by OSI in partnership with Roche’s Genentech in the U.S., Chugai in Japan, and Roche in the rest of the world. As a result of the latest Eurtac data, OSI and Genentech plan to initiate similar label-extension discussions with FDA, while Roche and OSI will work together on submissions to other health authorities.

The Eurtac study was designed and sponsored by the Spanish Lung Cancer Group and conducted by Roche in collaboration with investigators in France and Italy. Roche says the Eurtac study was the first at Phase III to evaluate Tarceva in a Western population with this distinct form of lung cancer.

Roche applied to the European regulatory authorities in June 2010 for a Tarceva label extension covering its use as first-line therapy in people with advanced NSCLC whose tumors express EGFR-activating mutations. The firm is also working with OSI to develop a PCR-based companion diagnostic to identify patients with NSCLC harboring EGFR-activating mutations.

Roche suggests about 10% of lung cancer patients in a Western population, and as many as 30% of Asian NSCLC patients, have tumors with EGFR-activating mutations. Tarceva is currently approved in markets including Europe and the U.S. as first-line maintenance therapy for NSCLC patients and as a second-line treatment for advanced or metastatic NSCLC, irrespective of EGFR mutation status.  

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