Aveo Oncology Renal Cell Carcinoma Drug OK’d

FDA has approved an Aveo Oncology NDA for Fotivda (tivozanib) for treating adults with relapsed or refractory advanced renal cell carcinoma (RCC) who have received two or more prior systemic therapies. The approval of the next-generation vascular endothelial growth factor tyrosine kinase inhibitor was based on data from the pivotal Phase 3 TIVO-3 study comparing Fotivda to sorafenib.

In the study, the main efficacy outcome measure was progression-free survival (PFS), assessed by a blinded independent radiology review committee. Other efficacy endpoints were overall survival (OS) and objective response rate (ORR). Median PFS was 5.6 months in patients treated with Fotivda compared with 3.9 months for those treated with sorafenib. Median OS was 16.4 and 19.2 months for the Fotivda and sorafenib arms, respectively. And ORR was 18% for Fotivda-treating patients and 8% for sorafenib-treated patients.