Tarceva Approved as Lung Cancer Maintenance Therapy

Posted on April 19th, 2010 by

The U.S. Food and Drug Administration (FDA) has expanded the approval of Tarceva® (erlotinib) to include maintenance therapy in patients with locally advanced or metastatic non–small cell lung cancer that has not progressed after four cycles of platinum-based first-line chemotherapy.

Lung cancer remains the leading cause of cancer death in the United States. Non–small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancers.

Treatment of advanced NSCLC often involves chemotherapy. Currently available combination chemotherapy regimens can improve the duration of survival as well as quality of life, but researchers continue to search for ways to improve outcomes for patients with this disease.

Tarceva is a targeted therapy that works by blocking a biological pathway referred to as the epidermal growth factor receptor (EGFR) pathway. The EGFR pathway is involved in cell growth and replication. Tarceva had previously been approved for treatment of NSCLC after failure of initial chemotherapy and is also approved for the treatment of advanced pancreatic cancer.

The safety and effectiveness of Tarceva maintenance therapy was evaluated in a Phase III clinical trial known as SATURN. Maintenance therapy refers to treatment that is given after initial treatment but before cancer progression. It is a relatively new approach to lung cancer treatment.

The study enrolled more than 880 patients with advanced NSCLC that had not progressed following initial, platinum-based chemotherapy. Half the patients received Tarceva maintenance therapy, and half received a placebo.

  • Compared with a placebo, overall survival was 23% better among patients treated with Tarceva, and progression-free survival was 41% better.
  • The most common side effects among patients treated with Tarceva were rash (49%) and diarrhea (20%).

Based on these results, the FDA expanded the approval of Tarceva to include maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer that has not progressed after four cycles of platinum-based first-line chemotherapy.

Reference: OSI Pharmaceuticals. FDA Approves Tarceva as a Maintenance Therapy for Advanced Non-small Cell Lung Cancer. Available at: http://investor.osip.com/releasedetail.cfm?ReleaseID=460783. Accessed April 19, 2010.

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