- John ShimkusRepresentative
- Tim MurphyRepresentative
- Marsha BlackburnRepresentative
- Michael BurgessRepresentative
- Bob LattaRepresentative
- Brett GuthrieRepresentative
- Leonard LanceRepresentative
- Bill CassidyRepresentative
- Joe PittsRepresentative
- Nita LoweyRepresentative
- Jerry NadlerRepresentative
- John DingellRepresentative
- Janet Woodcock, M.D.Director, Center for Drug Evaluation and Research (CDER)
- Mike RogersRepresentative
- Phil GingreyRepresentative
- Ed WhitfieldRepresentative
- Fred UptonRepresentative
- Robert PittengerRepresentative
- Frank PalloneRepresentative
To the FDA and the US Congress: Please Review BiovaxID Therapeutic Cancer Vaccine for Accelerated Approval
Sign to help make the BiovaxID vaccine available to lymphoma patients and to remind the FDA of its responsibility to patients to expedite safe and effective treatments. Therapeutic vaccines treat disease rather than prevent it. Vaccines boost a patient's own immune system to control the disease. Help make this therapeutic vaccine available to patients now.
Cathy McMorris Rodgers
- U.S. House of Representatives
- Director, Center for Drug Evaluation and Research (CDER)
Janet Woodcock, M.D.
- FDA Director, Center for Drug Evaluation & Research
Janet Woodcock, M.D.
Grant Application for Accelerated Approval of an Important Cancer Vaccine
We, the undersigned, who are cancer patients, survivors, caregivers, family members and friends of survivors and of those who have not survived, respectfully ask the FDA to recognize the urgent and immediate need of patients by expediting the accelerated approval process for the BiovaxID vaccine for use as consolidation therapy for patients with follicular non-Hodgkin’s lymphoma (FL) for the following reasons:
1. Despite recent improvements in therapies, FL is not considered curable. Current treatments generally slow the disease; but it invariably returns, requiring treatments with ever stronger drugs, with ever increasing risks and side-effects. Remission periods and response rates decrease with each successive treatment. For patients with this disease, this means a slow but certain death. Therefore, there is an urgent, unmet need for improved treatment options.
2. Consolidation therapies are meant to increase periods of remission. Two such therapies are approved by the FDA for FL: rituximab maintenance and radioimmunotherapy (specifically Zevalin™, which incorporates rituximab in its treatment protocol). In particular, the many FL patients whose cancer does not respond to rituximab or who are intolerant to it, need a safe and effective consolidation option.
3. The BiovaxID vaccine is an effective consolidation therapy. Long-term studies of the vaccine show the median duration of remission (Disease-Free Survival) increased from 30.6 months in non-vaccinated patients to 44.2 months in vaccinated patients.
4. Both FDA-approved consolidation therapies (maintenance rituximab and Zevalin™ radioimmunotherapy) have serious potential side effects, including severe immunosuppression and death, which are highlighted as black box warnings. Therefore, there is also an urgent, unmet need for a safe consolidation treatment.
5. BiovaxID fills the unmet need for a safe consolidation treatment. Unlike the current FDA-approved consolidation therapies, no deaths, no immune suppression, and no other serious side effects were experienced by patients who received the BiovaxID vaccine in three clinical trials spanning 18 years. The BiovaxID vaccine therefore represents a safer alternative for all FL patients.
6. By granting accelerated approval, patients would have access to this much-needed treatment while additional clinical trials could be funded and conducted to satisfy any additional data that the FDA seeks.
7. Finally, the BiovaxID vaccine was developed in large part with NCI funding. It represents a true achievement, not only in translating science to clinical practice but also in using tax dollars to do so. The denial of accelerated approval for this treatment equates to denying taxpayers a return on our own investment.
In summary, there is an urgent, unmet need for this vaccine. It has been studied for 18 years without a single vaccine-related serious adverse event. It has been shown to significantly increase disease-free survival. It is therefore both safe and effective and meets the criteria for accelerated approval.
For these reasons, we urge the FDA to immediately grant an application for accelerated approval for the BiovaxID vaccine. Furthermore, we ask our senators and representatives to intervene on our behalf by asking the FDA to grant an application for accelerated approval. We truly need every option available to us when we face this life-threatening disease.
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