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FDA Rejects Kidney Cancer Drug Tivozanib
Pivotal data deemed ‘uninterpretable’ (June 10)
The FDA has declined to approve the new drug application (NDA) for tivozanib (Aveo Pharmaceuticals), an investigational tyrosine kinase inhibitor, for the treatment of patients with advanced renal cell carcinoma (RCC).
In its complete response letter (CRL), the agency stated that the inconsistent progression-free and overall survival results and the imbalance in post-study treatments make the results of the pivotal TIVO-1 (TIvozanib Versus SOrafenib in 1st Line Advanced RCC) trial uninterpretable and inconclusive when making a risk-benefit assessment necessary for drug approval. The agency recommended that an additional clinical study be conducted 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.
Source: Aveo Pharmaceuticals; June 10, 2013.