Coulter Pharmaceutical, Inc. and SmithKline Beecham this week announced that the Biologics License Application (BLA) for radiodrug Bexxar (tositumomab, iodine I 131 tositumomab) has been accepted for filing by the U.S. Food and Drug Administration.
Bexxar is the only radioimmunotherapy that combines the targeting ability of a monoclonal antibody and the therapeutic power of radiation, with the precision of patient-specific dosing.
The radiolabeled monoclonal antibody attaches to a target marker found on Non-Hodgkin's lymphoma (NHL) affected cells thereby eliciting an immune response and delivers a dose of iodine 131 radiation to tumor cells. Bexxar is the first NHL therapy that is precisely dosed based on individual drug clearance rates.
The companies are seeking marketing approval of Bexxar for the treatment of relapsed or refractory, low-grade or transformed low-grade B-cell non-Hodgkin's lymphoma (NHL). If approved, Bexxar would be the first radioimmunotherapy to be made commercially available.
"We are delighted by the acceptance of the Bexxar BLA," said Michael F Bigham, president and chief executive officer of Coulter Pharmaceutical in a press release. "The acceptance represents an important milestone in the approval process for Bexxar. We look forward to working with the FDA and our partner SmithKline Beecham to make this product available to the patients who suffer from this devastating disease."
The BLA for Bexxar was received by the FDA on September 15, 2000, and the application has been assigned six-month priority review status. Upon acceptance of the BLA, Coulter Pharmaceutical will receive a $5 million equity investment from partner SmithKline Beecham.
"The data included in the BLA underscore the potentially important role of Bexxar in treating and managing patients with these forms of non-Hodgkin's lymphoma," commented Kevin Lokay, vice president and director of Oncology for SmithKline Beecham.
"We are pleased that Bexxar is on track for review by the FDA," said Ilene Penn-Miller, executive director of the Cure for Lymphoma Foundation. "Non-Hodgkin's lymphoma has historically been a difficult form of cancer to treat and there is a definite need for cutting edge therapies that could improve patient prognosis and possibly improve the likelihood of long-term survival."
Non-Hodgkin's lymphoma is a form of cancer that affects the blood and lymph tissues. NHL currently is the sixth leading cause of death among cancers in the United States and has the second fastest growing mortality rate. According to statistics from the National Cancer Institute, approximately 3 lakh people are afflicted with NHL in the United States alone. Of the total, the company estimates that approximately 1.4 lakh people have low-grade or transformed low-grade disease.
Coulter Pharmaceutical, Inc. is engaged in the development of novel drugs and therapies for the treatment of cancer and autoimmune diseases. The company currently is developing a family of cancer therapeutics based upon two drug development programs: therapeutic antibodies and targeted oncologics. Initial efforts in the targeted oncologics program are focused on the development of a tumor-activated peptide pro-drug version of doxorubicin to potentially treat certain solid tumor cancers. The company's therapeutic antibody program includes an antibody-based approach to block the Type I interferon receptor for the treatment of autoimmune diseases and transplant rejection.
On October 16, 2000, Coulter Pharmaceutical, Inc. announced its intention to merge with Corixa, a research- and development-based biotechnology company committed to treating and preventing autoimmune diseases, cancer and infectious diseases by understanding and directing the immune system.
SmithKline Beecham Oncology is committed to the research, development, manufacturing and marketing of therapeutic and supportive care products in oncology. Currently, SB Oncology markets Hycamtin (topotecan hydrochloride), Kytril (granisetron hydrochloride) and Compazine (prochlorperazine), and has novel agents in development.