Genentech/OSI Tarceva Shows Two-Month Improvement Over Placebo
This article was originally published in The Pink Sheet Daily
Executive Summary
A placebo-controlled, Phase III study presented at ASCO found a survival benefit in Tarceva patients with refractory non-small cell lung cancer. The rolling NDA is expected to be completed this summer.
You may also be interested in...
Iressa Promotion Halted; AstraZeneca To Highlight Tarceva Survival Benefit
Gefitinib fails to demonstrate a survival benefit in the Iressa Survival Evaluation in Lung cancer confirmatory trial. AstraZeneca will meet with FDA to determine whether accelerated approval licensure of Iressa will be withdrawn, CEO McKillop says.
Iressa Promotion Halted; AstraZeneca To Highlight Tarceva Survival Benefit
Gefitinib fails to demonstrate a survival benefit in the Iressa Survival Evaluation in Lung cancer confirmatory trial. AstraZeneca will meet with FDA to determine whether accelerated approval licensure of Iressa will be withdrawn, CEO McKillop says.
Genentech/OSI's Tarceva Will Be Detailed Alongside Herceptin
Tarceva approval comes just three-and-a-half months after application is completed and more than two months ahead of review deadline. Genentech and OSI will begin detailing the non-small cell lung cancer product immediately.