Sunday, July 5, 2009

Is the FDA really corrupt?

Spectrum Pharmaceuticals received the dreaded Complete Response Letter from the FDA Friday, requesting more data from their FIT study. This essentially delays the approval for Zevalin for first-line therapy up to 6 months. Zevalin is already FDA-approved for treatment for Non-Hodgkin's Lymphoma, but this pending approval was for extension to first-line therapy. Currently in the US, Zevalin is only approved for consolidation therapy after remission induction. But in Europe and many other countries, Zevalin has already been approved for first-line therapy also. Hence, the FDA is dragging their feet again, as more patients die due to lack of alternative and supplemental options for treatment of NHL. Are they purely incompetent, or our darker forces at work, namely other chemotherapy companies who stand to lose market share if Zevalin is approved for indication extension? You decide:

According to viva.vita International, April 28, 2008:

The decision by the European Commission to grant extended marketing authorization to Zevalin® is based on data from the pivotal Phase III First-Line Indolent Trial (FIT). It showed that Zevalin®, when used as first-line consolidation therapy, significantly prolonged the median progression-free survival time from 13.5 months (control arm) to 37 months (p<0.0001). The data were presented for the first time at the 49th Annual Meeting of the American Society of Hematology (ASH) in December 2007.

“It is particularly impressive that with one single infusion of Zevalin®, we have achieved prolongation of median progression-free survival by two years, with a favorable toxicity profile,” said Professor Anton Hagenbeek, Academic Medical Centre, Amsterdam, the Netherlands, lead investigator of the FIT trial. “The results also show that radioimmunotherapy is a very effective single agent in the treatment of follicular lymphoma.”

The FDA does not require additional studies, additional data, or data analysis. They only require data from the European FIT trials--data that already enabled EMEA approval. That's it. The FDA essentially agrees Zevalin's adverse effects are tolerable, and Zevalin has progression-free survival benefits. It destroys tumor cells--and saves lives. Yet, approval is delayed again.

This is exactly what is wrong with our government--federal agencies and czars. Incompetence and/or corruption. Hope and change. Astounding.

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