OSI Pharmaceuticals Inc. April 16 announced that the Food and Drug Administration has approved Tarceva (erlotinib) as a maintenance treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum based first-line chemotherapy.
Tarceva already is approved for people with advanced NSCLC whose cancer has grown or spread after receiving at least one course of chemotherapy. In December, an FDA advisory panel voted against expanding the use of Tarceva. In January, FDA said it would take an additional 90 days to review the supplemental new drug application for ...
Learn more about Bloomberg Law or Log In to keep reading:
Learn About Bloomberg Law
AI-powered legal analytics, workflow tools and premium legal & business news.
Already a subscriber?
Log in to keep reading or access research tools.