Tivozanib “Complete Response” Shows Increased Communications Can’t Always Save An NDA

11 Jun 2013

Aveo got extensive advice from FDA, but bad data and its decision not to conduct an additional trial led to a rejection for its kidney cancer application.

FDA’s formal rejection of Aveo Pharmaceuticals Inc.’soncologic tivozanib suggests that more frequent interactions between the agency and a sponsor immediately preceding and during an NDA review, as envisioned under PDUFA V, will not necessarily save an application from regulatory failure.

On June 10, Aveo announced receipt of an FDA “complete response” letter for tivozanib, a tyrosine kinase inhibitor, for treatment...