OSI Pharmaceuticals Inc announced that the US FDA has accepted for filing and review the New Drug Application (NDA) for the use of Tarceva (erlotinib HCl) as a monotherapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC) for whom chemotherapy has failed.
The acceptance of the NDA, as well as Roche's earlier filing of a European Marketing Application submitted in August to the European Health Authorities for Tarceva, satisfies milestone provisions for payments totalling $10 million by Genentech and Roche to OSI. Additional milestone payments will be paid by Genentech and Roche to OSI upon registration of Tarceva in the US and the European Union, respectively, and upon successful filing and registration of Tarceva in Japan. Further milestones are also due upon the successful filing and approval of Tarceva in a second oncology indication and upon the approval of the first two adjuvant oncology indications in the US, Europe and Japan, release from OSI Pharma said.
OSI also announced that Tarceva has been granted priority review classification by the FDA. Based on this priority review status, the FDA has six months from the NDA receipt date, or until January 30, 2005, to take action on the NDA filing.
The Tarceva NDA was previously granted Pilot 1 Status under the FDA's Pilot 1 Programme for Continuous Marketing Applications, a new programme designed for investigational products that have been given Fast Track status, such as Tarceva, and that have demonstrated significant promise in clinical trials as a therapeutic advance over available therapy for a disease or condition. Under the Pilot 1 status, the FDA is committed to reviewing each unit of the NDA within six months of each unit submission. The NDA filing for Tarceva is based on a pivotal phase III trial known as BR.21. OSI completed the NDA submission in July 2004.
The BR.21 trial was a double-blind, placebo-controlled study which included 731 patients with advanced NSCLC who had previously received one or two prior chemotherapy regimens. Tarceva demonstrated a 42 percent improvement in median survival and improved one-year survival by 45 percent. The trial also demonstrated statistically significant improvement in all secondary endpoints of the trial including time to symptom deterioration, progression-free survival and response rate. The study results make Tarceva the first and only targeted therapy to demonstrate an improvement in survival for NSCLC patients, the release says.
Tarceva is currently being evaluated in an extensive clinical development program by a global alliance of OSI Pharmaceuticals, Genentech, and Roche.