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Advocacy Issues >  Letter to Vice President Biden

Please help save radioimmunotherapy from extinction

Last update: 07/12/2016

 

July 6, 2016

 

Vice President Joe Biden

The White House

1600 Pennsylvania Ave., NY

Washington, DC 20500

 

Dear Vice President Biden:

I want first to express my heartfelt condolences for the loss of your dear son, Beau, and also to tell you about my deep appreciation for your commitment to accelerating advances in cancer research. 

I write to ask for your help in addressing a policy decision by the Nuclear Regulatory Commission (NRC) that requires oncologists to take a 700 hour course (on the full range of nuclear medicines) in order to give one medicine: prepackaged radioimmunotherapy (RIT) to their patients- a treatment that delivers radiation only to the type of cell affected by the malignancy.

Its apparent that its just not feasible for oncologists to take the entire course in order to be authorized to offer this one treatment to their patients.   The burdensome training requirement has contributed to the underutilization of radioimmunotherapy (RIT) in the community setting where 80% of patients receive the diagnosis of cancer and are treated.  

This is a classic catch 22 situation:  Most doctors who treat patients with lymphoma aren't authorized by the NRC to give RIT. Those who are authorized (nuclear medicine doctors) don't see these patients.  The sponsor of one remaining RIT drug, Zevalin, is losing money and may discontinue it.  Recently, Bexxar, a similar agent was discontinued for lack of profitability.

Vice President, Biden, I believe its evident that lives are being lost, tragically.   Here I can speak from personal experience.  My loved one was diagnosed with lymphoma.  She suffered relapsed following rigorous combination chemotherapy in 1997, just 6 months after her initial treatment.  For eight additional years she endured one harsh treatment after another. Each time the lymphoma was back and progressing even before her hair grew back.  In 2004, she received RIT following a short course of chemotherapy.  She has had no sign of lymphoma since allowing her to enjoy twelve years of normal life for which we are profoundly grateful. 

A remedy seems feasible and necessary:  have the NRC work with the sponsor of the drug to develop a focused course on how to safely administer a prepackaged radio-labeled antibody (as was done when it was first approved) a protocol that is very similar to the non-labeled Rituxan antibody that oncologists give routinely. 

Our letter to the Senate HELP committee follows, which provides additional background.  Its especially important I feel to consider the unique properties of this drug described in this letter, and to consider that the burdensome training requirement has negative implications for other types of cancer that may be treated with similar targeted radiotherapies.

Updated letter to the Senate HELP committee regarding an NRC policy decision that undermines patient access to an FDA-approved treatment for lymphoma in the community setting ... PAL letter

In it, we provide a snapshot of the unique properties of radioimmunotherapy copied here:

  - Zevalin radioimmunotherapy is an FDA approved treatment for indolent lymphoma

  - Radioimmunotherapy has unique properties:
      It takes about one week to give it, compared to many months of chemotherapy.
      It's the only non-chemotherapy-based approach with a high rate of durable remissions
      It's an important and unique choice for patients:
         - who must continue to work through or shortly after treatment
         - who cannot tolerate chemotherapy, because of advanced age, or specific comorbidities
         - who may prefer to avoid or substantially limit the on-treatment side effects specific to chemotherapy
            such as nausea, neuropathy, hair loss, gastric, and gastric and mucositis complications.

 Larson, Press: Radioimmunotherapy of human tumours - Europe PMC Article - Europe PMC http://bit.ly/1TXvYZt 

Seven Phase II studies and two Phase III studies have tested RIT in patients newly diagnosed with NHL who received front-line therapy either alone or as consolidation following chemotherapy.3, 6067

These studies have all demonstrated efficacy with ORRs of 90100% and CRs of 60100% (Figure 3A). Also, the CRs induced by this approach have been very durable, with median remission durations exceeding six years in many studies.
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Related resources:

bullet
Saving Access  to Zevalin in the Community Setting  PAL letter
bullet
Review: 90 Y-ibritumomab tiuxetan (Zevalin radioimmunotherapy):
a nearly forgotten opportunity http://bit.ly/29snERA
 
bullet
Rationale for continued study of RIT
 

- It's proven potential to induce durable remissions with a very short course of therapy

- It is an antibody-based therapy and therefore less likely to have adverse drug interactions
with other targeted drugs
- It is targeted to cd20, focused on b-cells, and therefore will have less impact on other effector cells
needed to mediate an immune response
bullet

 

 
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