FDA approves Fotivda for renal cell carcinoma subset
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The FDA approved tivozanib for treatment of adults with relapsed or refractory advanced renal cell carcinoma.
The approval applies to use of the agent by patients who received two or more systemic therapies.
Tivozanib (Fotivda, AVEO Oncology) is a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor.
The FDA based the approval on results of the randomized phase 3 TIVO-3 study, which included 350 patients with relapsed or refractory advanced renal cell carcinoma who received at least two prior systemic therapies.
Researchers randomly assigned patients 1:1 to tivozanib or sorafenib (Nexavar, Bayer). PFS assessed by blinded independent radiology review committee served as the main efficacy outcome measure. Other efficacy endpoints included OS and objective response rate.
Results showed longer median PFS (5.6 months vs. 3.9 months; HR = 0.73; 95% CI, 0.56-0.95) and a higher ORR (18% vs. 8%) in the tivozanib group. Median OS was numerically shorter in the tivozanib group than the sorafenib group (16.4 months vs. 19.2 months; HR = 0.97; 95% CI, 0.75-1.24).
The most common adverse events in the tivozanib group included fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough and stomatitis. The most common grade 3 or grade 4 laboratory abnormalities included decreased sodium, increased lipase and decreased phosphate.
“Today’s approval of Fotivda provides a new tool for treating patients with kidney cancer who have relapsed or become refractory to two or more prior systemic therapies,” Brian Rini, MD, chief of clinical trials at Vanderbilt Ingram Cancer Center, principal investigator of the TIVO-3 trial and a HemOnc Today Editorial Board Member, said in a press release issued by AVEO Oncology. “With advances in renal cell carcinoma treatment, patients are living longer, increasing the need for proven, well-tolerated treatment options in the relapsed or refractory setting.”
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