Supplemental New Drug Application Submitted for Erlotinib as a First-line Therapy in Genetically Distinct NSCLC

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Astellas Pharma US, Inc, announced it has submitted a supplemental New Drug Application (sNDA) to the FDA seeking approval for erlotinib (Tarceva) 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.

The sNDA submission is based on results of the international EURTAC trial, a prospective, randomized, controlled phase III trial evaluating the first-line use of erlotinib versus platinum-based chemotherapy in patients with EGFR-activating mutation-positive advanced NSCLC.

The cobas EGFR Mutation Test, a companion diagnostic,to identify patients with NSCLC whose tumors have EGFR-activating mutations, is currently under review by the Center for Devices and Radiological Health to support the EURTAC sNDA. It is estimated that as many as 10% of people in Western populations with lung cancer and 30% of Asian people with lung cancer have EGFR-activating mutations.

Study Design

The EURTAC trial was designed and sponsored by the Spanish Lung Cancer Group and conducted in Spain, France and Italy in cooperation with Roche. From February 2007 to January 2011, 174 predominantly Caucasian patients were randomly assigned to receive erlotinib or platinum-based chemotherapy. The primary endpoint was investigator-assessed progression-free survival.

An analysis of the EURTAC data, reflecting a total of 133 progression-free survival events, is included in the submission to the FDA. In the 133 progression-free survival event analysis, the median progression-free survival was 10.4 months in the erlotinib group and 5.1 months in the platinum-based chemotherapy group. Erlotinib reduced the risk of lung cancer getting worse by 66% (HR = 0.34, P < .0001).

The safety profile for erlotinib in the EURTAC study was consistent with previous studies of erlotinib in NSCLC. The most frequent (> 10%) adverse events were diarrhea, asthenia, rash, cough, and dyspnea in the erlotinib group and asthenia, anemia, nausea, neutropenia, and cough in the chemotherapy group. Two patient deaths in the chemotherapy arm and two patient deaths in the erlotinib arm were reported as related to treatment. ■




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