Tarceva Phase III EURTAC study in NSCLC patients with EGFR activating mutations meets primary endpoint

Genentech, a member of the Roche Group and OSI Pharmaceuticals, a wholly owned subsidiary of Astellas U.S. Holding Inc., a holding company owned by Astellas Pharma Inc., today announced that an independent data monitoring committee has recommended that the Phase III EURTAC study be stopped early because the study met its primary endpoint.

"We are pleased that the EURTAC study so quickly revealed Tarceva may be a viable alternative to platinum-based chemotherapy in newly diagnosed NSCLC patients with EGFR activating mutations," said Naoki Okamura, chief executive officer, OSI Pharmaceuticals. "The interim analysis of the EURTAC study reinforces the role that Tarceva may have in treating patients beyond the Asian population, which has a historically higher instance of EGFR activating mutations."

In June 2010, Roche applied to the European Medicines Agency (EMA) to extend the current label for Tarceva to include the first-line treatment of people with advanced NSCLC whose tumors harbor EGFR activating mutations. Based on the EURTAC study data, OSI and Genentech plan to discuss similar updates to the Tarceva label with the U.S. Food and Drug Administration (FDA). Roche and OSI will also collaborate regarding submissions with other health authorities. It is estimated that as many as one in 10 (10 percent) lung cancer patients in the Western population and one in three (30 percent) Asian patients with lung cancer have NSCLC with EGFR activating mutations.

Roche Molecular Systems and OSI are collaborating on the development of a PCR-based companion diagnostic test to identify people with NSCLC that harbors EGFR activating mutations.

SOURCE Genentech and OSI Pharmaceuticals

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