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FDA Accepts Supplemental NDA for Tarceva (Erlotinib) for Advanced Lung Cancer

Agency decision expected in second quarter of 2013 (Jan. 16)

The FDA has accepted for filing a supplemental new drug application (sNDA) for Tarceva (erlotinib, Astellas Pharma US) for first-line use in patients with locally advanced or metastatic non–small-cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR)-activating mutations. The application has been granted priority review status, and an FDA decision is expected in the second quarter of 2013.

It is estimated that 10% and 30% of Western and Asian populations with lung cancer, respectively, have EGFR-activating mutations.

The new sNDA submission is based on results from the phase III EURTAC (European Randomized Trial of Tarceva vs. Chemotherapy) study — a prospective, randomized, controlled trial that evaluated the first-line use of erlotinib versus platinum-based chemotherapy in patients with EGFR-activating mutation-positive advanced NSCLC. The study involved 174 predominantly Caucasian patients in Spain, France, and Italy. The primary endpoint was investigator-assessed progression-free survival (PFS).

EGFR is a protein that extends across the cell membrane. The epidermal growth factor (EGF) binds to the part of the EGFR protein that sits on the outside of the cell. Binding leads to activation of the EGFR protein, which triggers a complex signaling cascade inside the cell. This cascade, in turn, leads to accelerated cell growth and division and to the development of metastases, among other events. Some NSCLC tumors have activating mutations in the EGFR gene, which change the structure of the EGFR proteins and give them increased activity.

Tarceva (erlotinib) is approved for patients with advanced NSCLC whose cancer has not spread or grown after initial treatment with certain types of chemotherapy (maintenance therapy). Tarceva is also approved for patients with advanced 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 NSCLC.

Source: Astellas Pharma US; January 16, 2013.

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