(Renal Cancer) FDA Approves Fotivda Monotherapy

On March 10, 2021, the U.S. Food and Drug Administration (FDA) approved Fotivda (tivozanib) for patients with relapsed or refractory renal cell carcinoma (RCC) who have received two or more prior systemic therapies.

Efficacy was evaluated in the TIVO-3 trial (NCT02627963) — a multicenter, open-label, randomized trial comparing Fotivda versus Sorafenib in patients with relapsed or refractory RCC after two or more prior systemic therapies (including at least one VEGFR inhibitor). Patients were randomly assigned to either oral Fotivda 1.34 mg once daily for 21 consecutive days every 28 days, or oral Sorafenib 400 mg twice daily, continuing until disease progression or intolerable toxicity.

The primary endpoint was progression-free survival (PFS). Other endpoints were overall survival (OS) and objective response rate (ORR).

• Median PFS: Fotivda group 5.6 months vs. Sorafenib group 3.9 months
• Median OS: Fotivda group 16.4 months vs. Sorafenib group 19.2 months
• ORR: Fotivda 18% vs. Sorafenib group 8%

The most common adverse events (≥20%) were fatigue, hypertension, diarrhea, loss of appetite, nausea, dysphonia, hypothyroidism, cough, and mouth sores. The most common Grade 3 or 4 adverse events (≥5%) were hyponatremia, elevated lipase, and hypophosphatemia.

The recommended dose of Fotivda is 1.34 mg once daily (regardless of food intake), given for 21 consecutive days every 28 days, until disease progression or intolerable toxicity.

Source: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-tivozanib-relapsed-or-refractory-advanced-renal-cell-carcinoma

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