Friday, February 04, 2005

SINGLE COURSE OF TREATMENT WITH BEXXAR CAN INDUCE REMISSION IN FOLLICULAR LYMPHOMA PATIENTS, ACCORDING TO STUDY

A single one-week course of treatment with GlaxoSmithKline Plc and Corixa Corp.'s Bexxar (tositumomab/iodine I 131 tositumomab) can induce clinical and molecular remissions in patients with advanced follicular lymphoma, according to a study published in the Feb. 3 issue of The New England Journal of Medicine.

Researchers gave 76 patients with stage III or stage IV follicular lymphoma a single course of Bexxar treatment, which consisted of an initial dosimetric dose followed by a therapeutic dose one week later. This delivered 75 cGy of radiation to the entire body.

Ninety-five percent of the patients had a response to the treatment, and 75 percent had a complete response, defined as the disappearance of all disease for at least one month or an absence of change in minimal residual radiographic abnormalities for at least six months.

Of the 57 patients who had a complete response, 40 remained in remission for between 4.3 years and 7.7 years, the authors noted. The 5-year progression-free survival rate for all patients was an estimated 59 percent.

The Food and Drug Administration approved Bexxar to be used in treating follicular lymphoma after treatment with conventional chemotherapy has failed.

The authors of the study believe their data show pharmaceutical brand name Bexxar should be considered as an earlier course of treatment. They did stipulate, however, that randomized, comparative Phase III trials should be conducted to determine the ideal sequence of all available therapies.

"This (antibody) drug has been primarily relegated by most clinicians as a last-ditch effort," lead study author Dr. Mark Kaminski told Reuters. "What this is showing is if you treat the patients earlier, you get much more durable remissions without having to put the patient through chemotherapy after chemotherapy."

Tuesday, January 4, 2005

FDA APPROVES SBLA FOR EXPANDED USE OF BEXXAR

The Food and Drug Administration approved GlaxoSmithKline Plc's supplemental Biologics License Application for expanded use of Bexxar (tositumomab and iodine I 131 tositumomab).

The biotechnology brand name drug is now indicated for patients with CD 20 antigen-expressing relapsed or refractory, low-grade, follicular or transformed non-Hodgkin's lymphoma (NHL), including patients with Rituxan (rituximab)-refractory NHL.

The sBLA for Rituxan, which is jointly marketed by Genentech Inc. and Biogen Idec Inc., was filed on July 1, 2004, and was granted priority review status.

"This expanded indication establishes Bexxar as an important alternative for initial treatment of relapsed disease," said Kevin Lokay, vice president of oncology and acute care at GSK. "Now clinicians will be able to offer the potential benefits of Bexxar earlier in the treatment course for their patients with [NHL], and not have to wait for their disease to become refractory."

Tuesday, December 14, 2004

IN BRIEF: GLAXOSMITHKLINE PLC

GlaxoSmithKline Plc acquired worldwide rights and responsibilities for the manufacturing, development and commercialization of pharmaceutical brand name Bexxar (tositumomab and iodine I 131 tositumomab). The biotechnology brand name drug Bexxar, a targeted therapy for refractory or relapsed non-Hodgkin's lymphoma, was developed by Corixa Corp. and is co-marketed in the United States by Corixa and GSK. On Dec. 31, Corixa will transfer all Bexxar rights and responsibilities to GSK who will then provide developmental and sales milestones and royalties to Corixa based on Bexxar sales in the United States, Canada and Australasia.

Tuesday, July 1, 2003

FDA APPROVES GSK, CORIXA'S NON-HODGKIN LYMPHOMA TREATMENT BEXXAR

The Food and Drug Administration approved GlaxoSmithKline Plc and Corixa Corp.'s Bexxar (tositumomab and iodine I 131 tositumomab), which is now indicated to treat patients with CD20 positive, follicular, non-Hodgkin lymphoma, with or without transformation, whose disease is refractory to Genentech Inc.'s Rituxan (rituximab) and has relapsed following chemotherapy.

According to Corixa and GSK, which will jointly market the treatment in the United States, the biotechnology brand name drug Bexxar orders will start to be filled in approximately 30 days.

The combination of active ingredients in the biotechnology brand name drug Bexxar forms a radiolabeled monoclonal antibody capable of binding to the target antigen CD20 found on NHL cells. Consequently, a dose of radiation can be delivered directly to the tumor cells.

The FDA approval was based upon results of five studies that enrolled approximately 230 patients with follicular NHL whose disease had relapsed following Rituxan treatment or had not responded to Rituxan treatment, or who had never taken Rituximab and had relapsed following chemotherapy or were not responsive to chemotherapy.

Results of the studies showed an "impressive rate of complete and durable remissions" in patients treated with the biotechnology brand name drug Bexxar, according to Dr. Mark Kaminski, professor of internal medicine and co-director of the Leukemia/Lymphoma/Bone Marrow Transplant Program at the University of Michigan Comprehensive Cancer Center.

Shares of the biotechnology brand name drug Corixa closed at $7.74, up $0.54, or 7.5 percent, in heavy Nasdaq trading.