Tivozanib  approved for the treatment of adult patients with relapsed/refractory advanced renal cell carcinoma following 2 or more prior systemic therapies.

Fotivda tradename.

Phase 3 TIVO-3 trial demonstrated a significant improvement in progression-free survival (PFS) compared with sorafenib (Nexavar), with similar overall survival (OS), in patients with highly relapsed/refractory metastatic RCC.

The TIVO-3 study is the first positive phase 3 study in RCC patients who received 2 or more prior systemic therapies.

TIVo-3 is the first phase 3 RCC study to include a predefined population of patients who have received prior immunotherapy.

With this approval, I believe Fotivda represents an attractive intervention, and expect it to play a meaningful role in the evolving RCC treatment landscape.”

Prior findings showed an increased median PFS for tivozanib when compared with sorafenib at 5.6 months versus 3.9 months, respectively.

 The TIVO-3 study was a controlled, multicenter, open-label, phase III trial which randomized 350 patients with highly refractory metastatic RCC who had failed ≥2 prior regimens, including VEGF-TKI treatment, 1:1 to receive either oral tivozanib or sorafenib. 

Eighteen percent of patients in the tivozanib arm achieved partial response, compared with 8% of those in the sorafenib arm. 

The objective response rate was 34% for tivozanib versus 24% for sorafenib.

Most commonly adverse events: 

hypertension (38%), diarrhea (33%), fatigue (29%), and decreased appetite (27%).


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