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news.OSI Pharmaceuticals has submitted a supplemental new drug application with the FDA to use its Genentech co-developed anticancer drug Tarceva (erlotinib) plus gemcitabine in treatment-naive advanced pancreatic cancer patients.
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Tarceva is the first drug to significantly improve survival in a phase III trial when added to gemcitabine (Eli Lilly’s Gemzar) chemotherapy in first-line pancreatic cancer compared to gemcitabine alone.
The supplemental new drug application (sNDA) filing is based on a pivotal phase III multi-center, randomized, double-blind, placebo-controlled trial evaluating Tarceva in patients with locally advanced or metastatic pancreatic cancer.
The study demonstrated a statistically significant 23.5% improvement in overall survival for patients receiving Tarceva plus gemcitabine, compared to patients receiving gemcitabine plus placebo. Results showed that 24% of patients receiving Tarceva plus gemcitabine were alive after one year, compared to 17% of patients receiving gemcitabine plus placebo.
Progression-free survival in the Tarceva plus gemcitabine arm was also significantly improved, although there was virtually no difference in tumor response.
Tarceva is currently approved by the FDA as a monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.