|Dr. Richard Pazdur|
Two years ago, FDA cancer czar Richard Pazdur famously called out Aveo ($AVEO) for what the agency termed an incoherent and inconclusive Phase III study of tivozanib for renal cell carcinoma. TIVO-1 was such a badly run trial that the biotech, which at the time was building a commercialization arm, would have to run a new study in order to gain an approval.
The fallout was severe. The staff was bludgeoned, Astellas backed out of its partnership and a much reduced Aveo got a new CEO and went back to the drawing board.
Until today. According to Aveo, a pair of key advisers to the European Medicines Agency (EMA) has allowed that TIVO-1 may not have been the kiss of death that the FDA made it out to be. Buying in to the biotech's original argument that the overall survival data in the study--which showed a meager advantage over the comparator arm--could have been skewed by a crossover design, the biotech says it got a clear signal that the European agency would at least consider an application based on the data at hand.
Aveo's shares got at least a temporary reprieve today, shooting up about 30% at one point.
The rapporteur and co-rapporteur assigned to lead the evaluation of the drug for the EMA "did not see a 'blocking issue' with the OS trend," Aveo stated, adding that the biotech "clearly presented a credible story for the Rapporteurs to assess but one which would need to be supported with very careful reasoning." Aveo said that the rapporteurs also noted that they "cannot advise on [the] final outcome of the review."
That's a long way from an endorsement. But at this point, any positives found for TIVO-1 could only be a plus for Aveo. And the biotech used the occasion to promo its search for a new partner.
- here's the release