Tivozanib for Kidney Cancer Rejected by FDA

Zosia Chustecka

June 10, 2013

Tivozanib (developed by Aveo Oncology) will not be approved for use in the treatment of advanced renal cell carcinoma, the Food and Drug Administration (FDA) announced today. The agency followed the recommendation of its Oncologic Drugs Advisory Committee (ODAC), which voted in early May against recommending approval of the drug.

The committee had reviewed the pivotal TIVO-1 phase 3 trial of tivozanib in renal cell cancer, in which it was compared with the already marketed agent sorafenib (Nexavar, Onyx Pharmaceuticals). The results showed a significantly improved progression-free survival (PFS) for tivozanib compared with sorafenib, but the results for overall survival (OS) showed a nonsignificant trend favoring sorafenib. At the ODAC meeting, 1 of the committee members Mikkael Sekeres MD, MS, associate professor of medicine at the Cleveland Clinic Taussig Cancer Institute, in Ohio, said it would be difficult to explain these results to a patient.

In the FDA's letter to the manufacturer, the agency said the inconsistent PFS and OS results and imbalance in the post-study treatments make the TIVO-1 results "uninterpretable and inconclusive." The FDA also recommended that the company conduct an additional study to support approval of tivozanib in the treatment of advanced renal cell carcinoma.

Aveo has said that it will not further pursue this indication for tivozanib, but will continue with ongoing development of the drug in colorectal and breast cancer in the BATON phase 2 clinical trials. This will lead to a restructuring of the company with a loss of 140 jobs, around 60% of Aveo's workforce, the company announced in a statement in early May after the ODAC meeting.

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