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Tarceva (Erlotinib) Submitted for FDA Review for Treatment of NSCLC
A supplemental New Drug Application (sNDA) has been submitted to the FDA seeking approval for Tarceva tablets (erlotinib, Astellas Pharma US) 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. The sNDA submission is based on results from the international EURTAC trial — a prospective, randomized, controlled, phase III study that evaluated the first-line use of erlotinib versus platinum-based chemotherapy in patients with EGFR-activating, mutation-positive advanced NSCLC.
As many as 10% of people in Western populations with lung cancer and 30% of Asian people with lung cancer are estimated to have EGFR-activating mutations.
In the EURTAC (EURopean Randomized Trial of TArceva vs. Chemotherapy) study, 174 predominantly Caucasian patients were randomly assigned to receive erlotinib or platinum-based chemotherapy at centers in Spain, France, and Italy. The study’s primary endpoint was progression-free survival (PFS).
A total of 133 PFS events were observed. The median PFS 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 progression by 66% (hazard ratio = 0.34; P
EGFR is a protein that extends across the cell membrane. Epidermal growth factor (EGF) binds to the part of the EGFR protein located on the outside of the cell. This binding activates the EGFR protein, which in turn triggers a complex signaling cascade inside the cell that leads to a series of events, including accelerated cell growth and division, and the development of metastases. Some NSCLC tumors have activating mutations in the EGFR gene, changing the structure of EGFR proteins and causing 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 treatment). 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 Oncology; November 20, 2012.