sNDA Submitted for Tarceva as a First-Line Therapy in Genetically Distinct Form of NSCLC

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Astellas Pharma announced it has submitted a supplemental New Drug Application (sNDA) to the FDA seeking approval for Tarceva (erlotinib) tablets for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) activating mutations as detected by an approved test. Erlotinib is a human EGFR type 1/EGFR tyrosine kinase inhibitor.

The sNDA submission is based on results of the EURTAC (European Randomised Trial of Tarceva vs. Chemotherapy) 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. One hundred seventy four patients were randomly assigned to receive Tarceva or platinum-based chemotherapy. The primary endpoint was investigator-assessed progression-free survival (PFS). In the 133 PFS event analysis, the median PFS was 10.4 months in the Tarceva group and 5.1 months in the platinum-based chemotherapy group. Tarceva reduced the risk of lung cancer getting worse by 66% (HR=0.34, P<0.0001).

A companion diagnostic, the cobas EGFR Mutation Test (developed by Roche) to identify people with NSCLC whose tumors have EGFR activating mutations, is currently under review by the Center for Devices and Radiological Health (CDRH) to support the sNDA.

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 as a first-line treatment of locally advanced, unresectable or metastatic pancreatic cancer.

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