R&D In Brief
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Avastin/Tarceva combination lung cancer trial misses endpoint: The combination of Avastin (bevacizumab) and Tarceva (erlotinib) failed to meet its primary endpoint - median overall survival in patients with advanced non-small cell lung cancer whose disease progressed following platinum-based chemotherapy - in the Phase III BETA Lung trial, Genentech and OSI Pharmaceuticals announce Oct. 5. OSI and Genentech partner on Tarceva, a small molecule that targets the epidermal growth factor receptor pathway; Genentech and Roche market the blockbuster vascular endothelial growth factor inhibitor Avastin. While OSI and Genentech reserved many of the trial details for presentation to the Chicago Multidisciplinary Symposium in Thoracic Oncology next month, the firms noted that the combo improved progression-free survival and response rate in the 636-patient second-line NSCLC study. The companies also said median survival was similar in both arms of the trial. Surprisingly, the BETA control arm of Tarceva plus placebo produced a median survival of 9.2 months, exceeding the 6.7 months seen in Tarceva registration trials, which included both second- and third-line NSCLC patients. The companies expect data from another Avastin/Tarceva combination trial, the Phase III ATLAS study, in the first half of 2009; ATLAS is testing the pairing in first-line maintenance therapy of NSCLC patients who have responded to first-line Avastin plus chemotherapy
You may also be interested in...
R&D In Brief
AtheroGenics AGI-1067 dose range restricted in Phase III due to liver concerns: The high-dose 300 mg arm of AtheroGenics' Phase III ANDES trial will be discontinued due to liver toxicity concerns, the company announces Nov. 9. Additional analysis of an earlier Phase III study, ARISE, found rare adverse effects on the liver with a 300 mg dose of the oral anti-inflammatory antioxidant AGI-1067. ANDES was designed to elucidate subgroup effects seen in diabetic patients enrolled in ARISE, a pivotal atherosclerosis trial that failed to meet its primary cardiovascular event endpoint. AtheroGenics and then-partner AstraZeneca had hoped ARISE would support multiple claims for AGI-1067 in subgroups. After the stumble with ARISE, AtheroGenics shifted its focus for AGI-1067 from atherosclerosis to glycemic control in type 2 diabetes. ANDES started enrolling diabetes patients in August as a dose-ranging trial to confirm the ARISE diabetes findings. The trial will continue with the two lower-dose arms (75 and 150 mg); an interim analysis is planned for the second quarter of 2008...
FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011
September 2010 Approvals
Product