Bexxar (Tositumomab / Iodine I 131 Tositumomab) - Summary

BEXXAR SUMMARY

The BEXXAR therapeutic regimen (Tositumomab and Iodine I 131 Tositumomab) is an anti-neoplastic radioimmunotherapeutic monoclonal antibody-based regimen composed of the monoclonal antibody, Tositumomab, and the radiolabeled monoclonal antibody, Iodine I 131 Tositumomab.

The BEXXAR therapeutic regimen (Tositumomab and Iodine I 131 Tositumomab) is indicated for the treatment of patients with CD20 antigen-expressing relapsed or refractory, low grade, follicular, or transformed non-Hodgkin's lymphoma, including patients with Rituximab-refractory non-Hodgkin’s lymphoma. Determination of the effectiveness of the BEXXAR therapeutic regimen is based on overall response rates in patients whose disease is refractory to chemotherapy alone or to chemotherapy and Rituximab. The effects of the BEXXAR therapeutic regimen on survival are not known.

The BEXXAR therapeutic regimen is not indicated for the initial treatment of patients with CD20 positive non-Hodgkin’s lymphoma. (See ADVERSE REACTIONS, Immunogenicity.)

The BEXXAR therapeutic regimen is intended as a single course of treatment. The safety of multiple courses of the BEXXAR therapeutic regimen, or combination of this regimen with other forms of irradiation or chemotherapy, has not been evaluated.

See all indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Bexxar (Tositumomab / Iodine I 131 Tositumomab)

Co-Founder Of Microsoft Diagnosed With Non-Hodgkin's Lymphoma
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2009.11.17]
Paul Allen who co-founded the computer giant Microsoft with Bill Gates in the 1970s has been diagnosed with Non-Hodgkin's Lymphoma, 25 years after surviving Hodgkin's lymphoma. The news was announced in a memo to the staff of Allen's company Vulcan, by CEO Jody Allen, who is also Paul Allen's sister. A copy of the memo was also sent to the media.

FDA Approves New Drug For Rare Cancer Cutaneous T-Cell Lymphoma
Source: Blood / Hematology News From Medical News Today [2009.11.12]
The US Food and Drug Administration (FDA) has approved a new drug for treating patients with the rare white blood cell cancer Cutaneous T-cell Lymphoma (CTCL); the drug Istodax (romidepsin) is injectable and is marketed by Gloucester Pharmaceuticals Inc of Cambridge, Massachusetts. Every year, about 1,500 Americans are newly diagnosed with CTCL, a type of non-Hodgkin's lymphoma.

Istodax Approved for Cutaneous T-Cell Lymphoma
Source: MedicineNet Non-Hodgkins Lymphomas Specialty [2009.11.09]
Title: Istodax Approved for Cutaneous T-Cell Lymphoma
Category: Health News
Created: 11/6/2009 4:10:00 PM
Last Editorial Review: 11/9/2009

FDA Approves Gloucester Pharmaceuticals' ISTODAX(R) For Patients With Cutaneous T-cell Lymphoma
Source: Blood / Hematology News From Medical News Today [2009.11.06]
Gloucester Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) approved ISTODAX® (romidepsin) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. The approval of ISTODAX was based on objective disease response defined as the proportion of patients with confirmed complete response or partial response.

Approved Lymphoma Drug Shows Promise In Early Tests Against Bone Cancer
Source: Bones / Orthopaedics News From Medical News Today [2009.11.06]
A drug already approved for the treatment of lymphoma may also slow the growth of the most deadly bone cancer in children and teens, according to an early-stage study published online in the International Journal of Cancer. The study drug, Bortezomib, was found to be effective against bone cancer in human cancer cell studies and in mice.

more news >>

Published Studies Related to Bexxar (Tositumomab / Iodine I 131 Tositumomab)

Tositumomab and iodine-131 tositumomab produces durable complete remissions in a subset of heavily pretreated patients with low-grade and transformed non-Hodgkin's lymphomas. [2005.10.20]
PURPOSE: This study is an integrated efficacy analysis of the five clinical trials of tositumomab and iodine-131 tositumomab in patients with relapsed or refractory low-grade, follicular, or transformed low-grade non-Hodgkin's lymphoma (NHL) that resulted in the regulatory approval of the iodine-131 tositumomab by the US Food and Drug Administration... CONCLUSION: The tositumomab and iodine-131 tositumomab therapeutic regimen produces high response rates in patients with relapsed or refractory low-grade, follicular, and transformed low-grade NHL, with a sizable subgroup of patients achieving long-term durable responses.

Radiation therapy with tositumomab (B1) anti-CD20 monoclonal antibody initiates extracellular signal-regulated kinase/mitogen-activated protein kinase-dependent cell death that overcomes resistance to apoptosis. [2008.08.01]
CONCLUSIONS: These findings indicate that RT and type II anti-CD20 mAb combine to stimulate a prodeath function of the MEK-ERK1/2 pathway, which is able to overcome apoptotic resistance potentially explaining the efficacy of this modality in treating patients with chemoresistant disease.

Myeloablative 131I-tositumomab radioimmunotherapy in treating non-Hodgkin's lymphoma: comparison of dosimetry based on whole-body retention and dose to critical organ receiving the highest dose. [2008.05]
Myeloablative radioimmunotherapy using (131)I-tositumomab (anti-CD20) monoclonal antibodies is an effective therapy for B-cell non-Hodgkin's lymphoma. The amount of radioactivity for radioimmunotherapy may be determined by several methods, including those based on whole-body retention and on dose to a limiting normal organ. The goal of each approach is to deliver maximal myeloablative amounts of radioactivity within the tolerance of critical normal organs... CONCLUSION: Dosimetry based on whole-body retention will underestimate the organ doses, and a preferable approach is to evaluate organ-specific doses by accounting for actual radionuclide biodistribution. Myeloablative treatments based on the latter approach allow administration of the maximum amount of radioactivity while minimizing toxicity.

Comparison of 90Y-ibritumomab tiuxetan and 131I-tositumomab in clinical practice. [2007.11]
We retrospectively evaluated our single-center clinical experience with (90)Y-ibritumomab tiuxetan and (131)I-tositumomab for therapy of refractory non-Hodgkin's lymphoma (NHL). We evaluated the hypothesis that the patient-specific dosing regimen used with (131)I-tositumomab results in less bone marrow toxicity than does the weight-based dosing regimen used with (90)Y-ibritumomab tiuxetan... CONCLUSION: Both (90)Y-ibritumomab tiuxetan and (131)I-tositumomab were well tolerated. We observed response rates at the lower range of those reported in the literature, possibly because of referral bias, dose attenuation, and reasonably liberal acceptance criteria for a patient to receive therapy. Initial response assessments 12 wk after radioimmunotherapy predict longer-term response. (131)I-tositumomab caused significantly less severe declines in platelet counts than did (90)Y-ibritumomab tiuxetan and may be a more appropriate choice for patients with limited bone marrow reserve, but large, randomized, prospective trials are needed to better compare the performance of these 2 treatments.

Comparison of medium- and high-energy collimators for 131I-tositumomab dosimetry. [2007.09]
Residence time measurements obtained by serial whole-body conjugate-view imaging are commonly used in patient-specific dosimetry for radioimmunotherapy applications. In order to determine the effect of collimator selection on residence time measurements for (131)I, the accuracies of (131)I half-life measurements obtained with multiple gamma-camera and collimator combinations were investigated... CONCLUSION: There is no significant difference in (131)I half-life and residence time measurements obtained with medium- or high-energy collimators in dual-head or single-head imaging configurations.

more studies >>

Clinical Trials Related to Bexxar (Tositumomab / Iodine I 131 Tositumomab)

A Comparison Of Rituximab vs. Iodine I 131 Tositumomab Therapeutic Regimen (i.e., BEXXAR) For Patients With Relapsed Follicular Non-Hodgkins Lymphoma [Active, not recruiting]
Comparison of rituximab versus Iodine I 131 Tositumomab therapeutic regimen in subjects with follicular non Hodgkins B cell lymphoma. 506 subjects will be enrolled at 30 to 40 sites in the US, Canada, and Europe. Subjects will be randomly assigned to one of two treatment arms. In Arm A, subjects will receive 375 milligrams/meter2 (mg/m2 )of rituximab, given as an intravenous (IV) infusion once weekly for 4 weeks. In Arm B, subjects will undergo a two-phase treatment. In the first phase, termed the 'dosimetric dose', subjects will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of 5 millicuries (mCi) (0. 18 gigabecquerel [GBq]) of Iodine 131 Tositumomab (35 mg). Whole body gamma camera scans will be obtained three times (Day 0; Day 2, 3, or 4; and Day 6 or 7) following the dosimetric dose. The information derived from the scans will enable a patient specific dose to be calculated to deliver the desired total body dose of radiation (65 or 75 centigray [cGy]). In the second phase, termed the 'therapeutic dose', subjects in Arm B will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of the subject specific activity of Iodine 131-conjugated Tositumomab (35 mg). Thyroid blockade will be implemented 24 hours prior to the dosimetric dose and continued for 14 days following the therapeutic dose. Subjects on study will be followed for response and safety at Week 7, Week 13, and every three months for the first and second year, every six months for the third year, and then annually for the forth and fifth years; and then for vital status, additional therapy, and long term safety events through year ten. Follow Up after subsequent NHL therapy will be carried out to assess tolerance of next anti-lymphoma therapy, development of myelodysplasia (MDS)/acute myelogenous leukemia (AML), HAMA or hypothyroidism, unexpected safety issues, and death.

Expanded Access Study Of BEXXAR® For Low Grade And Transformed Low-Grade Non-Hodgkin's Lymphoma [No longer available]
This is a single arm, multi-center, expanded access study of Iodine I 131 Tositumomab (BEXXAR) therapeutic regimen for patients with relapsed or refractory low-grade or transformed low-grade non-Hodgkin's B-cell lymphoma. The primary objective is to make Iodine I 131 Tositumomab more broadly available to patients. Secondary endpoints will be to obtain additional safety and efficacy information for this treatment regimen. Post study drug administration follow-ups will continue for up to ten years. These will include blood-work and adverse event assessments for 13 weeks post dosing, patient response evaluations at Week 13, Months 6, 12, 18, 24, and Long-Term Follow-ups every 6 months until the elapse of 5 years from the dosimetric dose and then annually thereafter through year 10. Thyroid function will be monitored annually during Long-term follow-up.

Expanded Access Study of Iodine-131 Anti-B1 Antibody [Active, not recruiting]
The primary objective of this study is to make Iodine-131 Anti-B1 Antibody more broadly available to patients. Secondary endpoints of the study will be to obtain additional information on the efficacy and safety of Iodine-131 Anti-B1 Antibody.

Study of Untreated or Transformed Follicular Non-Hodgkin's Lymphoma With Fission-Derived Iodine I 131 Tositumomab [Completed]
The purpose of this study is to assess the blood pharmacokinetics in patients with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's lymphoma who have received a dosimetric dose of fission-derived iodine I 131 tositumomab.

Safety and Efficacy Study of Iodine-131 Anti-B1 Antibody for the Retreatment of Patients With Non-Hodgkin's Lymphoma [Active, not recruiting]
The purpose of this study is to enable retreatment with Iodine-131 Anti-B1 Antibody therapy for patients with non-Hodgkin's lymphoma (NHL) who previously responded (PR, CCR, or CR) for at least 3 months to Iodine-131 Anti-B1 Antibody therapy.

more trials >>