Tarceva Milestone for OSI Pharmaceuticals

The FDA grants priority review for the drug in pancreatic cancer.
Publish date:

The FDA accepted for review

OSI Pharmaceuticals'


application for Tarceva as a treatment with chemotherapy for pancreatic cancer.

Under the FDA's priority review regimen, the agency has six months to take action on the drug, which is marketed with



. Wednesday's news also triggers a $7 million milestone payment to OSI.

Tarceva is currently approved for lung cancer. In May, OSI said a phase 3 trial showed that the drug plus chemo improved overall survival rates in pancreatic cancer patients by more than 20%, extending life by a median 6.4 months compared with 5.9 months for a placebo.

About 32,000 people are expected to be diagnosed with pancreatic cancer in 2005. The disease is almost always fatal.

OSI added 26 cents to $40.66 Wednesday morning.