Tarceva is an oral tablet indicated for daily administration in the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
OSI said the drug is the only EGFR therapy shown to provide a statistically significant survival benefit in patients treated in first-line locally advanced or metastatic pancreatic cancer in combination with gemcitabine.
The FDA granted the drug, which is marketed with Genentech, priority review status and now has six months to take action on the application filing.
“We look forward to continuing to work closely with the FDA through this review process in hopes of bringing a new therapeutic treatment option to pancreatic cancer patients,” stated Colin Goddard, CEO of OSI Pharmaceuticals.