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FDA Approves Tivozanib for R/R Advanced RCC
On March 10, 2021, the FDA approved tivozanib (Fotivda; AVEO Pharmaceuticals), for the treatment of patients with relapsed or refractory advanced renal cell carcinoma (RCC) who previously received 2 or more systemic therapies.
Approval was based on the TIVO-3 trial, an open-label, multi-center trial of tivozanib versus sorafenib in patients with relapsed/refractory advanced RCC, who underwent 2 or 3 prior systemic treatments, including at least 1 VEGFR kinase inhibitor other than sorafenib or tivozanib.
Patients were randomized in a 1:1 ratio to receive tivozanib 1.34 mg once daily for 21 consecutive days every 28 days or sorafenib 400 mg twice daily continuously, until disease progression or unacceptable toxicity occurred.
The main efficacy end point was progression-free survival (PFS), assessed by a blinded independent radiology review committee. Secondary end points included overall survival (OS) and objective response rate (ORR).
Patients in the tivozanib arm saw a median PFS of 5.6 months (95% CI, 4.8-7.3), OS of 16.4 (95% CI, 13.4-21.9) months, and an ORR of 18% (95% CI, 12-24). Comparatively, those taking sorafenib had a median PFS of 3.9 months (95% CI, 3.7-5.6) , OS of 19.2 months (95% CI, 14.9-24.2) and an ORR of 8% (95% CI, 4-13).
The most common (≥20%) adverse reactions were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis.—Alexandra Graziano
Source: US Food and Drug Administration. FDA approves tivozanib for relapsed or refractory advanced renal cell carcinoma. March 10, 2021. www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-tivozanib-relapsed-or-refractory-advanced-renal-cell-carcinoma. Accessed March 11, 2021.
