FDA Approval Granted to Tivozanib for Advanced Renal Cell Carcinoma
Posted: Thursday, March 11, 2021
On March 10, the U.S. Food and Drug Administration (FDA) approved the kinase inhibitor tivozanib (Fotivda) for adults with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies. The recommended tivozanib dose is 1.34 mg once daily with or without food for 21 consecutive days every 28 days until disease progression or unacceptable toxicity.
The FDA approval was based on the results of the open-label multicenter TIVO-3 clinical trial. Patients with relapsed or refractory advanced renal cell carcinoma who had received two or three prior systemic treatments, including at least one VEGFR kinase inhibitor other than sorafenib or tivozanib were recruited. Patients were randomly selected to receive either 1.34 mg of tivozanib orally once daily for 21 consecutive days every 28 days or 400 mg of sorafenib orally twice a day continuously until disease progression or unacceptable toxicity.
The median progression-free survival was 5.6 months in the tivozanib arm compared with 3.9 months in the sorafenib arm. The median overall survival was 16.4 with tivozanib and 19.2 months with sorafenib. The overall response rate was 18% for the tivozanib arm and 8% for the sorafenib arm.
Common adverse reactions to tivozanib were reported in 20% or more of participants. They included fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis. The most common grade 3 or 4 laboratory abnormalities were decreased sodium, increased lipase, and decreased phosphate.
For full prescribing information, visit accessdata.fda.gov.