Genentech/OSI Tarceva Lung Cancer Trial Modified Following “Safety Signal”
Executive Summary
A "safety signal" detected during Genentech's Phase III trial of Tarceva (erlotinib) for first-line combination therapy in non-small cell lung cancer will not impact the rest of the agent's development program, the company said April 9
You may also be interested in...
Iressa User Fee Date Pushed To May; Will Advisory Cmte. Take Second Look?
FDA will take regulatory action on AstraZeneca's Iressa (gefitinib) by May 5
Iressa Cross-Over Study Could Show Clinical Benefit, AZ Says; ODAC Is Wary
AstraZeneca believes a controlled, cross-over trial could be used to confirm the sympom benefit of Iressa in refractory non-small cell lung cancer patients, VP-Medical Director of Oncology George Blackledge, MD, said during FDA's Oncologic Drugs Advisory Committee Sept. 24
Genentech/Novartis Xolair Indication Narrowed To Adult Allergic Asthma
Genentech and Novartis will seek a narrower label for the asthma biologic Xolair following the receipt of a "complete response" letter from FDA July 5.