Wednesday, November 28, 2012

Vaccine Petition

Change.org has a petition from Voices for Progress asking the FDA to consider approval of the BioVaxID vaccine for Follicular Lymphoma. I urge you to sign it.

I wrote about BioVax very recently. Initial clinical trial results looked great -- patients who took the vaccine added about 14 months to their disease-free survival. The FDA, however, rejected the request for approval because the results were somewhat old, and they wanted to see results in patients who are taking more currently popular treatments, particularly Rituxan.

The petition asks the FDA to consider the earlier results, and to keep in mind that, as a consolidation therapy (that is, a treatment that is given immediately after another treatment), BioVaxID will have fewer reported side effects than other consolidations like R maintenance or RadioImmunoTherapy.

It's all about options. That's what fNHL patients want. And need.

Lymphoma Rock Star Betsy de Parry (I'm going to suggest that she change her name legally to "Lymphoma Rock Star Betsy de Parry) wrote a nice piece for AnnArbor.com on Monday in  which she makes a case for the FDA to rant accelerated approval of BioVax. Accelerated approval gives doctors permission to use the treatment, provided the maker of the treatment agrees to conduct further trials to confirm its effectiveness. These "Phase 4" trials can then lead to full approval for the treatment, if they prove to be as effective as they seem likely to be.

As I write this, the petition still needs over 1000 signatures. Please consider adding your name.

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