Genentech, a member of the Roche Group (RHHBY, ROG) Tuesday said it has received approval from the U.S. Food and Drug Administration, or FDA, for Tarceva tablets used in initial treatment of people with metastatic non-small cell lung cancer.
The approval was based on the results of the Phase III study, named EURTAC, which evaluated the first-line use of Tarceva versus platinum-based chemotherapy in people with EGFR-activating mutation-positive advanced NSCLC.
"Ten to 30 percent of people worldwide with lung cancer have tumors that test positive for certain EGFR mutations. 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, " said Hal Barron, CMO, Genentech Global Product Development.
In the study, Tumor shrinkage was observed in 65 percent of patients treated with Tarceva and 16 percent of patients treated with chemotherapy. Meanwhile, the most common adverse events observed were diarrhea, weakness, rash, cough, shortness of breath and decreased appetite.
The FDA has also approved the cobas EGFR Mutation Test, which was developed by Roche and validated in the pivotal EURTAC study.
Tarceva is already approved in the U.S, 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.
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