FDA Advisors Give ‘Thumbs Down’ to Renal Cancer Drug, Tivozanib
Additional safety data needed (May 2)
According to a report from Reuters, the FDA’s Oncologic Drugs Advisory Committee (ODAC) has determined that the benefits of the investigational renal cancer drug tivozanib (Aveo Pharmaceuticals/Astellas Pharma) do not outweigh its risks.
The committee voted 13 to 1 against approval of tivozanib in the absence of an additional trial to prove that the drug is safe.
The FDA is not obligated to follow the recommendations of its advisory committees, but it usually does so.
In a briefing document issued prior to the ODAC’s review meeting, the agency noted that 517 patients with metastatic renal cell carcinoma were randomly assigned to receive either tivozanib or sorafenib in an open-label phase III trial.
In this study, patients treated with tivozanib showed a statistically significant improvement in progression-free survival (PFS) (hazard ratio [HR] = 0.80; P = 0.04). Median PFS was 11.9 months in the tivozanib arm versus 9.1 months in the sorafenib arm.
However, the final analysis of overall survival (OS) showed a trend toward a detrimental effect on OS with tivozanib (HR = 1.25; P = 0.11). Median OS was 28.8 months in the tivozanib arm and 29.3 months in the sorafenib arm.
The FDA asked its review committee to determine whether the results of this single open-label trial were sufficient to support the marketing approval of tivozanib for the treatment of patients with advanced renal cell cancer or whether an additional study was necessary before considering approval.
Tivozanib was submitted for regulatory review in September 2012.