FDA D.I.S.C.O. Burst Edition: FDA approval of Fotivda (tivozanib) for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies


Welcome back to the DISCO, FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. We’re back with a quick update on another recent FDA cancer drug approval.

On March 10, 2021, the FDA approved tivozanib (brand name Fotivda), a kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies.

Efficacy was evaluated in TIVO-3, a randomized 1:1, open-label, multicenter trial of tivozanib versus sorafenib in patients with relapsed or refractory advanced renal cell carcinoma who received two or three prior systemic treatments, including at least one vascular endothelial growth factor receptor kinase inhibitor other than sorafenib or tivozanib. Patients were randomized to either tivozanib for 21 consecutive days every 28 days or sorafenib continuously, until disease progression or unacceptable toxicity.

The main efficacy outcome measure was progression-free survival, assessed by a blinded independent radiology review committee. Other efficacy endpoints were overall survival and objective response rate.

Median progression-free survival was 5.6 months in the tivozanib arm compared with 3.9 months for those treated with sorafenib. Median overall survival was 16.4 months for patients in the tivozanib arm compared with 19.2 months in the sorafenib arm. The objective response rate was 18% for the tivozanib arm and 8% for the sorafenib arm.

The most common adverse reactions occurring in more than 20% of patients were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis. The most common grade 3 or 4 laboratory abnormalities occurring in more than 5% of patients were decreased sodium, increased lipase, and decreased phosphate.

The FDA approved this application 3 weeks ahead of the FDA goal date.

Full prescribing information for this approval can be found on the web at www.fda.gov/drugsatFDA.

Health care professionals should report serious adverse events to FDA’s MedWatch Reporting System at www.fda.gov/medwatch.

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