Tarceva’s Lack Of EGFR Status Data Reflects “Emerging Problem” With Targeted Oncologics, FDA Says
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA review documents for Genentech/OSI’s lung cancer therapy suggest the agency should “proactively” pursue inclusion of receptor status data for targeted anticancer drugs. Tarceva’s potential lack of survival benefit in receptor-negative patients observed in Phase III subgroup led FDA to require postmarketing studies, despite OSI’s insistence that EGFR status is “not important.”