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Bexxar (Tositumomab / Iodine I 131 Tositumomab) - Summary

 
 



WARNINGS

Hypersensitivity Reactions, including Anaphylaxis: Serious hypersensitivity reactions, including some with fatal outcome, have been reported with the BEXXAR therapeutic regimen. Medications for the treatment of severe hypersensitivity reactions should be available for immediate use. Patients who develop severe hypersensitivity reactions should have infusions of the BEXXAR therapeutic regimen discontinued and receive medical attention (see WARNINGS).

Prolonged and Severe Cytopenias: The majority of patients who received the BEXXAR therapeutic regimen experienced severe thrombocytopenia and neutropenia. The BEXXAR therapeutic regimen should not be administered to patients with >25% lymphoma marrow involvement and/or impaired bone marrow reserve (see WARNINGS and ADVERSE REACTIONS).

Pregnancy Category X: The BEXXAR therapeutic regimen can cause fetal harm when administered to a pregnant woman.

Special requirements: The BEXXAR therapeutic regimen (Tositumomab and Iodine I 131 Tositumomab) contains a radioactive component and should be administered only by physicians and other health care professionals qualified by training in the safe use and handling of therapeutic radionuclides. The BEXXAR therapeutic regimen should be administered only by physicians who are in the process of being or have been certified by GlaxoSmithKline in dose calculation and administration of the BEXXAR therapeutic regimen.

 

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.


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NEWS HIGHLIGHTS

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

Combination therapy incorporating 3 new agents shows promise as treatment for aggressive lymphoma
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2016.04.20]
New research from Roswell Park Cancer Institute (RPCI) shows that promising cancer drugs used in combination can have significant therapeutic impact on a particularly aggressive subtype of diffuse...

Lymphoma overrides a key protein's quadruple locks
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2016.03.22]
Protein chemists at Johns Hopkins report they are closer to explaining why certain blood cancers are able to crack a molecular security system and run rampant.

Young Black, Hispanic Hodgkin Lymphoma Patients Face Worse Outcomes: Study
Source: MedicineNet Non-Hodgkins Lymphomas Specialty [2016.02.04]
Title: Young Black, Hispanic Hodgkin Lymphoma Patients Face Worse Outcomes: Study
Category: Health News
Created: 2/3/2016 12:00:00 AM
Last Editorial Review: 2/4/2016 12:00:00 AM

Young, poor African Americans and Hispanics have harder time beating hodgkin lymphoma
Source: Health Insurance / Medical Insurance News From Medical News Today [2016.02.01]
UC Davis researcher also links insurance status with higher mortality.African American and Hispanic adolescents and young adults fare far worse than their white counterparts when faced with a...

Lymphoma Survivors May Not Get All Recommended Follow-Up Care
Source: MedicineNet Hodgkins Disease Specialty [2016.01.15]
Title: Lymphoma Survivors May Not Get All Recommended Follow-Up Care
Category: Health News
Created: 1/15/2016 12:00:00 AM
Last Editorial Review: 1/15/2016 12:00:00 AM

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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.

Phase III randomized study of rituximab/carmustine, etoposide, cytarabine, and melphalan (BEAM) compared with iodine-131 tositumomab/BEAM with autologous hematopoietic cell transplantation for relapsed diffuse large B-cell lymphoma: results from the BMT CTN 0401 trial. [2013]
relapsed diffuse large B-cell lymphoma (DLBCL)... CONCLUSION: The B-BEAM and R-BEAM regimens produced similar 2-year PFS and OS

Phase III randomized intergroup trial of CHOP plus rituximab compared with CHOP chemotherapy plus (131)iodine-tositumomab for previously untreated follicular non-Hodgkin lymphoma: SWOG S0016. [2013]
15, 2008... CONCLUSION: There was no evidence of a significant improvement in PFS comparing

Six of 12 relapsed or refractory indolent lymphoma patients treated 10 years ago with 131I-tositumomab remain in complete remission. [2011.06]
The purpose of our study was to update the safety and efficacy results of radioimmunotherapy in relapsed or resistant indolent or transformed non-Hodgkin lymphoma... CONCLUSION: Optimal patient benefit might be obtained in indolent lymphoma when administering radioimmunotherapy up-front in combination with chemotherapy and rituximab treatment. However, these results show that radioimmunotherapy alone achieved long-lasting remissions in 6 of 12 (50%) indolent lymphoma patients in relapse after 1 or multiple chemotherapies.

Tositumomab and iodine I 131 tositumomab (Bexaar). [2011.04]
Tositumomab and iodine I 131 tositumomab (Bexaar) therapeutic regimen targets monoclonal antibodies against the CD20 antigen expressed in non-Hodgkin lymphoma. This article reviews the mechanism of action and clinical indications for this regimen..

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

Comparison Of Rituximab Versus Tositumomab and Iodine I 131 Tositumomab (BEXXAR� Therapeutic Regimen) For Patients With Relapsed Follicular Non-Hodgkins Lymphoma [Completed]
Comparison of rituximab versus Iodine I 131 Tositumomab Therapeutic Regimen (Tositumomab and Iodine I 131 Tositumomab or the Bexxar Therapeutic Regimen, formerly called Iodine-131 Anti-B1 Antibody) 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.

Clinical Trial of Consolidation Treatment With Iodine I 131 Tositumomab for Multiple Myeloma [Active, not recruiting]
This study is for patients with newly diagnosed or relapsed multiple myeloma. The main purpose of this study is to see how their disease responds to consolidation treatment (treatment aimed at further decreasing cancer cells) with a radioactive antibody (protein) called iodine I 131 tositumomab (known by the tradename Bexxar®) and also to look at the side effects which occur with this type of treatment. The investigators will also be looking at how long disease responds to treatment, if it responds at all, and how long patients who have had this treatment survive. Bexxar is a monoclonal antibody (protein) to which radioactive iodine 131 is attached. The monoclonal antibody in Bexxar (tositumomab), targets a protein called CD20 found on the surface of a variety of B-cells, including lymphoma cells, and some myeloma cells. The antibody is given as an infusion and finds its way to these cells. The radioactive iodine attached to the antibody delivers radiation directly to these cells which works to harm or kill the cancer cells. Approximately 20-25% of patients with multiple myeloma have this protein on the surface of their tumor cells. In addition, this protein was found on the surface of myeloma stem cells. While myeloma stem cells represent a minority of all myeloma cells (less than 5%), these cells are resistant to chemotherapy and are believed to be responsible for a recurrence of the disease after chemotherapy. In this study, Bexxar will be used after patients complete a course of chemotherapy and have residual myeloma cells left in their body. The Investigators are hoping that the treatment with Bexxar will decrease and possibly eliminate residual myeloma cells resistant to chemotherapy.

Comparison of Rituxan Versus Bexxar When Combined With Carmustine, Etoposide, Cytarabine and Melphalan (BEAM) With Autologous Hematopoietic Stem Cell Transplantation (ASCT) [Completed]

Safety and Efficacy Study of I-131 Tositumomab in Patients With Relapsed/Refractory Hodgkin's Lymphoma [Recruiting]
The purpose of this study is to find the highest safe dose of Iodine-131 Tositumomab (Bexxar®) that can be given to patients who have relapsed/refractory Hodgkin's lymphoma, what side effects these patients get when they take Bexxar® and if Bexxar® is effective in treating relapsed/refractory Hodgkin's lymphoma. Bexxar® works by delivering doses of radiation to cancer cells.

Safety and Efficacy of Iodine-131 Anti-B1 Antibody for Non Hodgkin's Lymphoma (NHL) Patients With Greater Than 25% Bone Marrow Involvement [Completed]
This is a phase I, dose escalation, open-label, multicenter study of iodine-131 Anti-B1 Antibody for patients with non-Hodgkin's lymphoma (NHL) who have more than 25% bone marrow involvement with NHL. Prior studies with Iodine-131 Anti B1 Antibody for the treatment of NHL have excluded patients with more than 25% bone marrow involvement with NHL. To be eligible, patients must have been previously treated and failed to achieve an objective response on or relapse during or following their last treatment. Patients will undergo two dosing phases while on study. In the first phase, termed the "dosimetric dose", patients will receive 450 mg unlabeled Anti-B1 Antibody infused over 1 hour or longer followed by 35 mg of Anti-B1 Antibody of which 1-2 mg has been labeled with 5 mCi of Iodine-131 infused over 20 minutes. Whole body camera scans will be obtained on Day 0, Day 2, 3, or 4, and Day 6 or 7 following the dosimetric dose. Using dosimetric data from three imaging time points, a patient-specific dose of Iodine-131 Anti-B1 Antibody to deliver the desired total body dose of radiotherapy will be calculated. In the second phase, termed the "therapeutic dose", 450 mg Anti-B1 Antibody will be infused over 1 hour or longer followed by 35 mg of Anti-B1 Antibody labeled with the subject-specific dose of Iodine-131 to deliver the desired total body radiation, infused over 20 minutes. The dose escalation will be initiated at 45 cGy and will be increased in 10 cGy increments until the maximum tolerated dose (MTD) is reached. Patients will be treated with either saturated potassium iodide, Lugol's solution, or potassium iodide tablets starting at least 24 hours prior to the infusion of the dosimetric dose and continuing for 14 days following the last infusion of the therapeutic dose. The primary endpoint is to determine the maximum tolerated dose of Iodine-131 Anti B-1 Antibody in patients with previously treated NHL having more than 25% bone marrow involvement with lymphoma. Secondary endpoints include assessment of response rate, duration of response, relapse-free survival, time to treatment failure, safety, and survival.

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Page last updated: 2016-04-20

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