New York, NY - April 20, 2010 -Roche and OSI Pharmaceuticals have gained FDA approval for the use of Tarceva as a maintenance treatment for non-small cell lung cancer. The FDA’s decision comes despite an earlier negative opinion from its advisory panel which voted 12-1 against recommending approval for Tarceva’s expanded use. Tarceva will now have to compete with Alimta in the maintenance setting.
Tarceva (erlotinib; OSI Pharmaceuticals/Genentech/Roche/Chugai) is already approved by the FDA and EMA (European Medicines Agency) for the second- and third-line treatment of advanced non-small cell lung cancer (NSCLC). This latest approval means that Tarceva will be available as a maintenance therapy for patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, for both squamous and non-squamous histologies.
The approval was based on data from the pivotal Phase III SATURN trial. In the SATURN trial, 889 patients with no evidence of disease progression after four cycles of chemotherapy were randomized to receive either 150mg of Tarceva per day (438 patients) or placebo (451 patients) until disease progression. Patients treated with Tarceva had a 41% improvement in progression-free survival (PFS, the primary endpoint) compared to placebo (p value <0.0001), and a 23% improvement in overall survival (OS, a secondary endpoint) compared to placebo (p value = 0.0088). The median survival of patients receiving Tarceva was 12 months compared to a median survival of 11 months for patients receiving placebo.
Tarceva is an orally available epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. EGFR is part of the ErbB pathway, which is hyperactivated or dysregulated in many cancers, thereby leading to uncontrolled cell growth. Tarceva has been a blockbuster drug for Roche and OSI with global sales of $1.2 billion in 2009.
Tarceva will now compete with Alimta (pemetrexed; Eli Lilly), which was approved by the FDA as a maintenance therapy for non-squamous NSCLC in 2008. In the study that led to Alimta’s approval, 663 patients were randomized to receive Alimta or a placebo after four cycles of platinum-based chemotherapy. The median overall survival was 13.4 months in the Alimta arm compared to 10.6 months in the placebo arm.
Maintenance therapy is a relatively new paradigm in the treatment of NSCLC and it is questionable whether or not the clinical benefits provided by Alimta or Tarceva justify the impact on quality of life and added cost. The clinical data supporting Tarceva’s approval did not demonstrate a clear advantage to using it in preference to Alimta which has the advantage of being first to market in the maintenance setting for non-squamous NSCLC. Tarceva may be predominantly used for squamous NSCLC where it is currently the only approved maintenance therapy.
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