Europeans Begin Formal Review of Lymphoma Vaccine BiovaxID

Fourteen months ago I profiled Biovest and the company's innovative therapeutic follicular lymphoma vaccine, BiovaxID. To the amazement and disappointment of many, the US Food & Drug Administration denied market approval, requesting another Phase III trial, dealing the company a major setback.

In the wake of that letdown, a coalition of patients and advocates launched a petition to pressure the FDA to bring BiovaxID to market. It wasn't enough.

Today, better news.

Biovest is reporting that the European Medicines Agency (EMA) has accepted its Marketing Authorization Application (MAA) for BiovaxID (submitted to EMA under the name Dasiprotimut-T Biovest). This means that Biovest’s submission is complete and that the formal review process to secure market approval in the European Union is underway.

If accepted, BiovaxID will be labeled as a consolidation therapy in patients with non-Hodgkin’s follicular lymphoma who have achieved complete remission following frontline therapy.

One of the FDA’s issues with BiovaxID was that they felt that this patient population was already sufficiently served by consolidation with the monoclonal antibody rituximab. Yet even if BiovaxID failed to fully outperform rituximab, at the very least the data demonstrated that it was as good as rituximab in terms of efficacy and phenomenally better in terms of side effects and adverse events. This is because BiovaxID is made from the patient’s own tumor. The most extreme side effect of BiovaxID reported was redness at the injection site.

In a release, Biovest’s Chief Executive Officer Carlos F. Santos, Ph.D. said,

EMA’s acceptance of our Marketing Authorization Application for BiovaxID marks a major milestone in our efforts to bring BiovaxID to the European market. If approved, BiovaxID will receive marketing authorization in the 28 EU member states, as well as in Iceland, Liechtenstein and Norway. This vaccine, if approved, will offer patients diagnosed with non-Hodgkin’s follicular lymphoma, and who have achieved a first complete remission, a truly personalized therapy to delay or to prevent tumor recurrence following the completion of induction therapy. Using currently available treatments, more than half of the patients diagnosed with non-Hodgkin’s lymphoma achieve complete remissions, but will almost always suffer from tumor relapse and will ultimately require re-treatment for ongoing disease. We hope to change that with BiovaxID.

Just last week, I wrote about the FDA’s wisdom in rejecting Cell Therapeutics’ pixantrone, and the foolishness of the European Union and the UK in accepting it.

In the case of BiovaxID, I believe the FDA got it wrong. I hope that they get it right in Europe.

Source: Biovest

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For a deeper dive into BiovaxID, please click on the following links.

Part I: On the Trail of the Follicular Lymphoma Vaccine.

Part II: BiovaxID And The FDA's Recent Cancer Drug Approval Record

Part III: An Introduction to Consolidation Therapy

Part IV: Interview with Eduardo Sotomayor MD