June 16, 2009
FDA accepts supplemental NDA for Tarceva (erlotinib) for maintenance treatment of NSCLCOSI Pharmaceuticals announced that the FDA has accepted for filing and review the supplemental New Drug Application (sNDA) for the use of Tarceva (erlotinib) as a first-line maintenance treatment for patients with advanced non-small cell lung cancer (NSCLC) who have not progressed following first-line treatment with platinum-based chemotherapy. This sNDA filing is based on a pivotal Phase 3 placebo-controlled, randomized, double-blind trial known as SATURN. The SATURN study met both of its co-primary endpoints by demonstrating a statistically significant 41% improvement in the time patients live without their disease worsening (as measured by progression free survival, or PFS) compared with placebo (Hazard Ratio = 0.71, p-value <0.00001; a hazard ratio of less than one indicates a decreased risk of disease progression and a p-value of less than 0.03 indicates statistical significance) and a 45% increase in the time patients live without their disease worsening compared with placebo in the sub-set of patients who were determined to have tumors expressing the EGFR gene by Immunohistochemistry (IHC) (Hazard Ratio for PFS = 0.69, p-value <0.0001).
Tarceva, a tyrosine kinase inhibitor, is already indicated as a monotherapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen and in combination with gemcitabine for first-line treatment of locally advanced, unresectable or metastatic pancreatic cancer.
For more information call (800) 572-1932 or visit www.osip.com.