AVEO's NDA Hits Roadblock for Tivozanib in Advanced Renal Cell Carcinoma

AVEO Oncology announced that it has received a Complete Response Letter from the FDA stating that the FDA will not approve in its present form the New Drug Application (NDA) for AVEO'S investigational agent tivozanib for the treatment of patients with advanced renal cell carcinoma (RCC).

In the letter, the FDA stated that the inconsistent progression-free survival and overall survival results and imbalance in post-study treatments make the TIVO-1 results uninterruptable and inconclusive when making a risk-benefit assessment necessary for drug approval, and recommended that AVEO conduct an additional clinical study to support approval of tivozanib for the treatment of advanced RCC. The FDA also stated that the proposed dissolution acceptance criterion was not supported by the provided dissolution data, and would need to be updated and resubmitted.

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