Pharmacist Medication Insights: Tivozanib for Renal Cell Carcinoma

Tivozanib was the first therapy approved by the FDA for adult patients with relapsed or refractory advanced renal cell carcinoma following 2 or more prior systemic therapies.

In March, the FDA granted approval to tivozanib (Fotivda, AVEO Oncology) as the first therapy for adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following 2 or more prior systemic therapies.

Tivozanib is an oral, next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI).

The approval is based on the TIVO-3 study, which compared tivozanib to sorafenib in relapsed or refractory advanced RCC following 2 or more prior systemic therapies. The approval is also supported by 3 additional trials in RCC and includes safety data from more than 1000 clinical trial subjects, according to the press release.

Study participants were randomized 1:1 to receive either tivozanib or sorafenib. The main efficacy outcome measure was progression-free survival (PFS) and other efficacy endpoints were overall survival (OS) and objective response rate (ORR).

According to the press release, the median PFS was 5.6 months in the tivozanib arm compared to 3.9 months in the sorafenib arm. Median OS was 16.4 and 19.2 months for the tivozanib and sorafenib arms, respectively, whereas the ORR was 18% for those receiving tivozanib and 8% for those receiving sorafenib.