OSI Pharmaceuticals and Genentech’s Tarceva Non-Small Cell Lung Cancer Therapy

On November 18, 2004 OSI Pharmaceuticals and Genentech, Inc. announced that the FDA had approved their cancer therapeutic Tarceva™ (erlotinib). The oral tablet is intended for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. The FDA’s approval of Tarceva was based on results [...]

Sanofi-Synthelabo’s Eloxatin for Postsurgical Treatment of Stage III Colon Cancer

On November 5, 2004 Sanofi-Synthelabo’s Eloxatin™ (oxaliplatin for injection) received US FDA approval for use in combination with conventional chemotherapy (5-flurouracil and leukovorin) for the postsurgical treatment of stage III colon cancer patients. According to the company, this is the first new chemotherapy approval for the adjuvant treatment of colon cancer in over a decade. [...]

Iressa (Gefitinib) for Non Small Cell Lung Cancer

On April 29, 2004 The New England Journal of Medicine and Science magazine published early release articles online concerning Iressa. Both of these studies identified a sub-group of patients with non small cell lung cancer (NSCLC) and specific mutations in the EGFR gene. These articles concluded that screening for these mutations might identify patients who [...]

Avastin

n early December 2003, Genentech announced that the Biologics License Application (BLA) for Avastin (bevacizumab) as a first line therapy in metastatic colorectal cancer had been submitted to the FDA. Genentech requested and received a ‘Priority Review’ designation.