Zevalin
(Ibritumomab tiuxetan) works like a smart bomb. It's an antibody with a radiation attached that
seeks and binds to cells that have a receptor called CD20 -- present on both normal
and malignant mature b-cells.
Once
bound to the target cells, Zevalin delivers radiations, which enhances the
killing effect of the antibody.
Normal
b-cells will recover in about 9 months because the parent b-cells do not
have the CD20 receptor.
Rituxan
is administered prior to Zevalin (an unbound antibody) with the goal of
clearing the majority normal b-cells and thus reducing the toxicity of
Zevalin.
Who it's for
(Indication): Patients with relapsed or
refractory low-grade, follicular, or transformed B-cell non-Hodgkin's
lymphoma, including patients with Rituximab refractory follicular
non-Hodgkin's lymphoma.
The effects of Zevalin on survival is unknown. Source: Zevalin.com
pdf
Mechanism of Action: After Y-90 ZEVALIN (the therapeutic component of the ZEVALIN regimen) enters the bloodstream, the monoclonal antibody ibritumomab recognizes and attaches to the CD20 antigen, allowing beta radiation emitted by the Yttrium-90 isotope to penetrate and damage the B-cell as well as neighboring cells.
Pivotal Clinical Trial Results: A pivotal Phase 3 randomized, controlled trial was conducted in 143 patients with relapsed or refractory, low-grade or follicular NHL or transformed B-cell NHL comparing the ZEVALIN therapeutic regimen vs. Rituximab administered alone. The overall response rate in 73 patients who received the ZEVALIN therapeutic regimen was 80% (with 30% complete responses) compared to an overall response rate of 56% (with 16% complete responses) in patients who received Rituximab alone. The estimated mean duration of response was 13.9 months for patients receiving the ZEVALIN therapeutic regimen and 11.8 months for patients receiving Rituximab. Median time to disease progression in the intent-to-treat populations was 10.6 months and 10.1 months for the ZEVALIN therapeutic regimen and Rituximab, respectively.
Treatment with ZEVALIN: The entire ZEVALIN therapeutic regimen is delivered over 7 to 9 days. Patients then receive follow-up care by a physician for at least an additional 12 weeks. The ZEVALIN therapeutic regimen can be administered entirely on an outpatient basis and no isolation or lead shielding is necessary.
Where can I receive treatment?
You can use the Treatment
Site Locator to locate centers that administer Zevalin
Reimbursement assistance:
Contact the ZEVALIN Customer Care Program:
1-866-298-8433 Monday through Friday 9:00am to 8:00pm EST Web
This program transfers the logistics of managing reimbursement,
scheduling, and other time-consuming duties to a dedicated ZEVALIN
Coordinator
Repeated Use of ZEVALIN: The entire ZEVALIN therapeutic regimen is intended as a one-time treatment. The safety profile from multiple courses of the ZEVALIN therapeutic regimen or other forms of therapeutic radiation preceding, following, or in combination with the ZEVALIN therapeutic regimen has not been established.
Ongoing Studies Clinical studies at major medical centers are currently investigating the use of the ZEVALIN therapeutic regimen in a variety of other lymphoma subtypes including aggressive disease. The ZEVALIN therapeutic regimen is also being studies in a number of different treatment strategies including combinations with front-line and salvage chemotherapy regimens and as part of autologous and allogeneic stem cell transplantation.
Contraindicated
(not for): Patients with known Type I hypersensitivity or
anaphylactic reactions to murine proteins or to any component of this
product, including Rituxan, yttrium chloride, and indium chloride.
Zevalin should not be administered to patients with >25%
lymphoma marrow involvement and/or impaired bone marrow reserve -
Source: Zevalin.com
Click to enlarge
Resources:
Does spleen involvement
preclude use of radioimmunotherapy?
Residual splenomegaly in a patient who has otherwise successfully
responded in other sites following chemotherapy for lymphoma is another
reason for performing a splenectomy. In these cases, the procedure may be
performed for both diagnostic and therapeutic reasons; it can determine if
the splenomegaly is due to persistent lymphoma, and should this be true,
it can potentially eliminate the focus of residual disease. A less common
indication for splenectomy that may be seen more frequently in the future
is to allow patients to become eligible for enrollment onto novel
treatment protocols. An example of this is in patients with lymphoma
refractory to conventional chemotherapy who were treated with
radioimmunotherapy using a radiolabelled anti-CD20 antibody.
In some of these patients, splenomegaly was found to complicate
treatment, as the large organ served as an “antigen sink”, effectively
decreasing the dose of radionuclide available to treat other sites of
disease. Thus, pretreatment splenectomy
may be indicated to eliminate this complicating factor.
Related Topics
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New: Zevalin in Mantle
Cell Lymphoma touchbriefings.com
pdf 2007
Conclusion: Radiotherapy is an active treatment modality in MCL.
Ibritumomab radioimmunotherapy (Zevalin) is an interesting alternative to
other consolidation methods. In younger patients subjected to intensive
chemotherapy followed by autologous transplant, it may be an element of a
transplant conditioning regimen (i.e. Z-BEAM). In elderly patients, the
role of zevalin consolidation should be further investigated in a phase
III trial.
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Radiation dosimetry results and safety correlations from
90Y-ibritumomab tiuxetan radioimmunotherapy for relapsed or refractory
non-Hodgkin's lymphoma: combined data from 4 clinical trials. J Nucl Med.
2003 Mar;44(3):465-74. PMID:
12621016
Relapsed or refractory NHL in patients with adequate bone marrow
reserve and <25% bone marrow involvement by NHL can be treated safely
with (90)Y-ibritumomab tiuxetan RIT on the basis of a fixed,
weight-adjusted dosing schedule. Dosimetry and pharmacokinetic results do
not correlate with toxicity.
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Salvage therapy for primary Central
Nervous System lymphoma with (90)Y-Ibritumomab and Temozolomide. J
Neurooncol. 2007 Jul;83(3):291-3. Epub 2007 Jan 24. PMID:
17245621
Aggressive initial treatment of Primary Central Nervous System Lymphoma
(PCNSL) has achieved prolonged survival and occasional cures. However,
some patients do not respond to initial therapy and others relapse after
an initial remission. The optimal salvage regimen is not known and many
different strategies have been proposed. In this report we describe the
efficacy of a combination of (90)Y-Ibritumomab Tiuxetan (Zevalin) and
Temozolamide as a maintenance therapy for recurrent PCNS Lymphoma in two
patients that are both alive and in complete remission after 9 and 10
months respectively. This combination merits further study and provides a
reasonable therapeutic alternative for older patients with progressive
PCNSL.
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Zevalin: Risk of MDS/AML update www.fda.gov
| Zevalin_PI.pdf
"Myelodysplastic syndrome (MDS) and/or acute myelogenous leukemia
(AML) were reported in 5.2% (11/211) of patients enrolled in clinical
studies and 1.5% (8/535) of patients included in the expanded-access
trial, with median follow-up of 6.5 and 4.4 years, respectively. Among the
19 reported cases, the median time to the diagnosis of MDS or AML was 1.9
years following treatment with the Zevalin therapeutic regimen; however,
the cumulative incidence continues to increase."
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Analysis of the Incidence of Treatment-Related
Myelodysplastic Syndrome and Acute Myelogenous Leukemia in Registration
and Compassionate-Use Trials of Ibritumomab Tiuxetan Radioimmunotherapy (RIT).
Session Type: Oral Session ASH
2006
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| Zevalin update: Biogen Idec and FDA notified
healthcare professionals of revision to BOXED WARNINGS, WARNINGS, and
ADVERSE REACTIONS sections of the Prescribing Information to describe
severe cutaneous (skin) or mucocutaneous (mucosal linings) reactions, some
with fatal outcome, that have been reported in association with the
Zevalin therapeutic regimen in the post-marketing experience. fda.gov/medwatch
| medpagetoday.com
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Follow-up results of a phase II study of ibritumomab
tiuxetan radioimmunotherapy in patients with relapsed or refractory
low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma and
mild thrombocytopenia. Cancer Biother Radiopharm. 2004 Aug;19(4):478-81. PMID:
15453962
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ASCO 2003 - Report on Zevalin - durable responses;
safety as second- or third-line therapy Buswire
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4-year data:
Safety of Yttrium-90 Ibritumomab Tiuxetan Radioimmunotherapy for Relapsed
Low-Grade, Follicular, or Transformed Non-Hodgkin's Lymphoma. J Clin Oncol.
2003 Apr 1;21(7):1263-70. PMID: 12663713 PubMed
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Durable Remissions Obtained with Zevalin in Recurrent Follicular Lymphoma
CancerConsultants.com
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Zevalin:
IDEC
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Subsequent Therapy Well Tolerated in Patients
Previously Treated with
Zevalin (tm) 411cancer.com
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Zevalin Reimbursement Support IDEC
Information on how to navigate through the complex maze of
health insurance requirements
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Zevalin Safe For Patients Who Have Had Prior Radiation
OncoLink
10-9-02 2002
(scroll down after reaching page)
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Subsequent Therapy Well Tolerated in Patients
Previously Treated with
Zevalin (tm) www.vacancer.com
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Biologic License Application PDF
| PDF-Help
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90Y ibritumomab (Zevalin) in aggressive non-Hodgkin's
lymphoma: analysis of response and toxicity Year: 2002 Abstract No: 1061
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90Y ibritumomab tiuxetan (Zevalin) radioimmunotherapy
does not preclude effective delivery of subsequent therapy for
lymphoma Year: 2002 Abstract No: 1064
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90Y-ibritumomab tiuxetan (Zevalin) radioimmunotherapy
for transformed B-cell non-HodgkinÝs lymphoma (NHL) patients Year:
2002 Abstract No: 51
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Randomized controlled trial of yttrium-90-labeled
ibritumomab tiuxetan radioimmunotherapy versus rituximab immunotherapy
for patients with relapsed or refractory low-grade, follicular,
or transformed B-cell non-Hodgkin's lymphoma. J Clin Oncol. 2002
May 15;20(10):2453-63. PMID: 12011122
PubMed
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Ibritumomab tiuxetan radioimmunotherapy for patients
with relapsed or refractory non-Hodgkin lymphoma and mild
thrombocytopenia: a phase II multicenter trial. Blood. 2002 Jun
15;99(12):4336-4342. PMID: 12036859 PubMed
(Lower dose used.)
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RIT and risk of MDS:
Treatment-related myelodysplastic syndrome (MDS) and AML in
patients treated with Zevalin radioimmunotherapy. J Clin Oncol.
2007 Sep 20;25(27):4285-92. Epub 2007 Aug 20.
PMID:
17709799
Analysis of data from patients ... (746 patients) ...
incidences of t-MDS and t-AML (0.7% per year after treatment) are
consistent with that expected in patients with NHL who have had
extensive previous chemotherapy treatment and do not appear to be
increased after treatment with the ibritumomab tiuxetan regimen.
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