Tarceva access trial
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
OSI/Genentech's new Phase IIIb Tarceva trial, announced Sept. 10, is intended to provide access to the non-small cell lung cancer therapy before approval, Genentech says. Patients will be enrolled in the open-label Access to Care, Tarceva (ACT) study up until FDA's decision, which is expected in early 2005, and may remain in the study until nine months post-approval. Survival and response rates are co-primary endpoints. Although Tarceva (erlotinib) showed a two month survival benefit in its pivotal study, the design of the trial would make it easier to collect additional survival data after commercial approval. An earlier Phase III combination study did not show a survival benefit (1Pharmaceutical Approvals Monthly Feb. 1, 2004, In Brief). Genentech plans to submit the data at the end of the study...