March 10, 2021

The U.S. FDA has approved AVEO Pharmaceuticals’ Fotivda® (tivozanib) to treat relapsed or refractory advanced renal cell carcinoma (RCC) in adults who have had two or more prior systemic therapies. It is the first FDA-approved therapy for this indication.

Renal cell carcinoma is the most common form of kidney cancer and is most often diagnosed in individuals between 50 and 70 years old. The risk of RCC is increased by certain factors such as smoking, dialysis treatment, hepatitis C infection, cystic kidney disease, certain genetic conditions, and chronic abuse of certain prescription and/or over-the-counter medications. Patients whose disease is advanced following at least two prior lines of systemic therapy can be faced with limited treatment options and a poor prognosis.

In a clinical study, Fotivda delivered an objective response rate (ORR) of 18%, median progression free survival (PFS) of 5.6 months, and median overall survival (OS) of 16.4 months. It was compared to treatment with sorafenib, a current standard of care, which delivered an 8% ORR, median PFS of 3.9 months, and median OS of 19.2 months.

Recommended dosing with Fotivda is 1.34mg taken by mouth once daily with or without food for 21 days, followed by seven days off treatment, in a 28-day cycle that should be repeated until disease progression or unacceptable toxicity occur. Dose modification may be necessary if the patient has hepatic impairment and/or experiences adverse reactions.

AVEO plans to launch Fotivda March 31, 2021. Pricing is not yet available.

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