SOUTH SAN FRANCISCO, Calif. and NORTHBROOK, Ill. – May 14, 2013 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) and Astellas Pharma US, Inc. (“Astellas”), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), today announced that the U.S. Food and Drug Administration (FDA) has approved Tarceva® (erlotinib) tablets for the initial (first-line) treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors have certain epidermal growth factor receptor (EGFR) activating mutations as detected by an FDA-approved test. The FDA also approved the cobas® EGFR Mutation Test, which was developed by Roche and validated in the pivotal EURTAC study. In the study, treatment with Tarceva demonstrated that patients lived longer without their disease getting worse (median progression-free survival [PFS] 10.4 months vs. 5.2 months; HR=0.34; p<0.001 [95 percent CI  0.23 to 0.49]) compared to chemotherapy. The safety profile for Tarceva in the EURTAC study was consistent with previous studies of Tarceva in NSCLC.

“Ten to 30 percent of people worldwide with lung cancer have tumors that test positive for certain EGFR mutations,” said Hal Barron, M.D., chief medical officer and head, Genentech Global Product Development. “People with this type of lung cancer now have the option to use a personalized medicine as their initial treatment to help them live longer without their disease worsening.”

“With this approval, more patients across all lines of therapy have access to Tarceva,” said Sef Kurstjens, M.D., chief medical officer, Astellas Pharma Inc. “This new indication is emblematic of Astellas’ commitment to continue our development efforts in lung cancer and precision medicine.”

“Increasingly, doctors and patients rely on diagnostics to help guide personalized treatment decisions. The approval of the cobas EGFR Mutation Test highlights the importance of sensitive, accurate tests that can be conducted in time to inform crucial treatment decisions,” said Paul Brown, head of Roche Molecular Diagnostics. “At Roche, we have a deep commitment to providing personalized healthcare options and are currently developing companion diagnostics for more than half of the medicines in our pipeline.”

In the United States, Tarceva is already approved, irrespective of histology or  biomarker status for people with advanced-stage NSCLC whose cancer has not spread or grown after initial treatment with certain types of chemotherapy (maintenance treatment). Tarceva is also approved for patients with advanced-stage NSCLC whose cancer has spread or grown after receiving at least one chemotherapy regimen (second- or third-line treatment). Tarceva is not meant to be used at the same time as certain types of chemotherapy for advanced NSCLC.

This latest FDA approval for Tarceva is based on the results of the Phase III EURTAC study, which evaluated the first-line use of Tarceva versus platinum-based
chemotherapy in people with EGFR-activating mutation-positive advanced NSCLC. Tumor shrinkage (response rate) was observed in 65 percent of patients treated with Tarceva and 16 percent of patients treated with chemotherapy.  The most frequent (greater than or equal to 30 percent) adverse events in Tarceva-treated patients were diarrhea, weakness, rash, cough, shortness of breath and decreased appetite.  The most frequent Grade 3-4 reactions in Tarceva-treated patients were rash and diarrhea.

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