Dr. Atkins on the FDA Approval of Tivozanib in Relapsed/Refractory Advanced RCC

Michael B. Atkins, MD, deputy director of the Georgetown Lombardi Comprehensive Cancer Center, and the Scholl Professor and vice chair of the Department of Medical Oncology at Georgetown University Medical Center, discusses the FDA approval of tivozanib (Fotivda) in relapsed/refractory advanced renal cell carcinoma (RCC).

On March 10, 2021, the FDA approved tivozanib for the treatment of adult patients with relapsed/refractory advanced RCC following 2 or more prior systemic therapies. The regulatory decision was based on findings from the phase 3 TIVO-3 trial, in which tivozanib improved progression-free survival vs sorafenib (Nexavar) in patients with highly relapsed/refractory metastatic RCC.

Tivozanib offers patients with advanced RCC another effective treatment option, says Atkins. Additionally, the TIVO-3 study marks the first positive phase 3 study in patients with RCC who have received 2 or more prior therapies, as well as the first positive study in the era of immunotherapy in RCC, Atkins explains.

Although tivozanib may not be the most efficacious drug among other VEGF TKIs, the agent has a good therapeutic index and is highly selective, says Atkins. As such, it is likely one of the most tolerable VEGF TKIs, Atkins explains. As such, efficacy may not play as significant a role in the utility of tivozanib, which could be selected for patients who want a tolerable therapy and good quality of life, concludes Atkins.