CBER Review Committee
Product/Committee Chair: Terrye Zaremba, Ph.D.
Product Review Staff Terrye Zaremba, Ph.D., Product Reviewer
Leon Epps, Ph.D., Radiation Chemistry
Keith Webber, Ph.D. Dep. Div.
Kathryn Stein, Ph.D., Director, DMA
Clinical Review Staff: Steven Litwin, M.D., Medical Reviewer
George Mills, MD, Medical Reviewer,
Harvey Luksenburg, M.D., Medical
Kaushik Shastri, M.D., Medical Reviewer
Susan Jerian, M.D., Team Leader
Patricia Keegan, M.D., Dep. Div. Director
Biostatistical Review Staff: Satish C. Misra, Ph.D.
Ghanshyam Gupta, Ph.D., Branch Chief
Peter A. Lachenbruch, Ph.D., Div. Director
Clinical Toxicology & Pharmacology: David Green, Ph.D., Branch Chief,
Regulatory Project Manager: Mike Noska
Compliance/BIMO: Mary Andrich, M.D.
Product: Bexxar (Proprietary name); Tositumomab (murine monoclonal antibody directed against the CD20 antigen) and Iodine I-131-labeled Tositumomab (USAN names)
Proposed indication in Original BLA September 14, 2000
"Iodine I 131 tositumomab is indicated for the treatment of patients with relapsed or refractory low-grade or transformed low-grade, CD20-positive, B-cell non-Hodgkin’s lymphoma."
Revised indication submitted ------------
Corixa submitted a request for standard approval of Bexxar based on demonstration of efficacy in patients with Rituximab refractory follicular non-Hodgkin’s lymphoma. In addition, Corixa requested accelerated approval based on the existence of long-term durable responders (time-to-progression [TTP] of at least one year) in patients with relapsed or refractory, follicular or transformed non-Hodgkin’s lymphoma and who were culled from multiple clinical studies.
The revised proposed indication being sought is
"BEXXARÒ is indicated for the treatment of patients with relapsed or refractory low-grade, follicular or transformed low-grade B-cell non-Hodgkin’s lymphoma (NHL) including patients with Rituximab refractory follicular non-Hodgkin’s lymphoma. Determination of the effectiveness of the BEXXAR therapeutic regimen in relapsed or refractory patient population is based on the existence of long-term durable responders (time-to-progression [TTP] of at least one year) in multiple clinical studies."
The Investigational New Drug Application (IND) for Bexxar was received on October 13, 1989.
Milestones prior to submission of BLA
06/29/99 BLA Application (STN 103906/0) Submitted
08/27/99 FDA Refusal-to-file (RTF) Letter Issued
Milestones for BLA STN 125011/0
09/14/00 BLA Application (STN 125011/0) Submitted
03/16/01 FDA Complete Review (CR) Letter Issued
03/12/02 FDA Complete Review Letter Issued
05/31/02 Request for Dispute Resolution Submitted
06/26/02 FDA Other Letter re: Dispute Resolution Issued