OSI 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.