sNDA Accepted, Priority Review Granted to Tarceva for Genetically Distinct NSCLC

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Astellas announced that the FDA has accepted for filing a supplemental New Drug Application (sNDA) for Tarceva (erlotinib) for first-line use in people 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. Erlotinib is a human EGFR type 1/EGFR tyrosine kinase inhibitor.

The sNDA submission is based on results of the international EURTAC trial, a prospective, randomized, controlled Phase 3 trial evaluating the first-line use of Tarceva vs. platinum-based chemotherapy in patients with EGFR activating mutation-positive advanced NSCLC.  A pre-market approval application for a companion diagnostic, the cobas EGFR Mutation Test (developed by Roche), has also been submitted to the FDA.

Tarceva is approved for the maintenance treatment of patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as well as the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Tarceva is also approved in combination with gemcitabine (Gemzar; Lilly) as a first-line treatment of locally advanced, unresectable or metastatic pancreatic cancer.

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