Today I'm very pleased to be writing about a movement to grant accelerated approval to the therapeutic lymphoma vaccine BiovaxID.
This past July I wrote about BiovaxID and was intrigued by its potential. I wasn't alone in fully expecting the FDA to grant accelerated approval to Biovest for the vaccine.
Instead, the FDA said Biovest needed to carry out another confirmatory trial, delivering a significant blow to the company and the many thousands of patients who could benefit. I began writing BiovaxID: On the Trail of the Follicular Lymphoma Vaccine, a multi-part look at this therapeutic vaccine from several angles. It's a series I've not yet finished.
Then the other day I received the news from my colleague Liz Hart McMillan that a petition had been launched by patients, caregivers, patient advocates and physicians not connected with either the clinical trials nor Biovest to press the government to grant accelerated approval to BiovaxID. Accelerated approval simply means that the FDA allows the vaccine to reach the market, but the company must still carry out a confirmatory trial.
There is a longer and more detailed explanation at the petition page.
McMillan, who is coordinating the campaign, is a 6-year diffuse large B-cell lymphoma (DLBCL) survivor. She is also the founder of support groups for both follicular lymphoma and mantle cell lymphoma patients, the founder of Hope for Lymphoma (now 16 private Facebook support and education groups) and an advocate who coordinates educational symposia for lymphoma patients at medical centers across the United States featuring key lymphoma thought leaders. The petition--the drive itself--couldn't possibly be in better hands.
BiovaxID is an important therapeutic vaccine that can greatly improve the quality of life of patients with follicular lymphoma. It is not a cure. But it is a much better way of treating these patients after they have had frontline chemotherapy than the current standard of care.
BiovaxID is an autologous vaccine. This means that the vaccine is created from the patient's own tumor cell—not from mice or anything else that is foreign to the body and could cause an allergic reaction.
You can access the petition HERE.
You can read more about BiovaxID through an excellent write-up on the vaccine and the petition by author and advocate Betsy de Parry, as well as through my own ongoing series BiovaxID: On the Trail of the Follicular Lymphoma Vaccine.
You can also visit the Biovest website for more information.
The petition still needs more signatures. I hope you'll consider visiting the page and adding yours.