FDA Rejects Renal Cancer Drug Tivozanib

The FDA has rejected the oral VEGF receptor tyrosine kinase inhibitor tivozanib, intended for the treatment of renal cell carcinoma, according to the drug's developer.

AVEO Oncology, of Cambridge, Mass., said it has received a Complete Response letter from the agency, saying the drug will not be approved based on the current new drug application.

The ruling is not a surprise -- in May, an FDA advisory committee voted 13-1 that the drug should not be approved.

The company said the FDA's letter cited inconsistent progression-free and overall survival results, as well as imbalance in post-study treatments.

Because of those findings, the agency letter said, the results -- from a single study -- are "uninterpretable and inconclusive when making a risk-benefit assessment necessary for drug approval."

The agency suggested the company conduct a new clinical trial to support approval.