Monthly Archives: March 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.

Merck, the manufacturer of Keytruda® (pembrolizumab), has voluntarily withdrawn the drug’s FDA-approved indication to provide third-line treatment of metastatic small cell lung cancer (SCLC) in patients whose disease has progressed on or after platinum-based chemotherapy and at least one other prior line of therapy.

The indication was granted accelerated FDA approval in June 2019. Continued approval was contingent upon completion of a post-marketing requirement to establish the superiority of treatment with Keytruda based on overall survival (OS) rates in a clinical study. Although Keytruda met a study endpoint for progression-free survival, it did not meet the OS endpoint.

This change affects only the indication for third-line treatment of metastatic SCLC. It does not affect the approval of Keytruda’s more than two dozen other indications for cancer treatment.

Keytruda’s SCLC withdrawal follows a similar move by Bristol Myers Squibb. The manufacturer had been granted accelerated FDA approval for Opdivo® (nivolumab) in 2018 to provide third-line treatment for SCLC that had progressed after platinum-based chemotherapy and at least one other line of therapy. Like Keytruda, Opdivo did not meet the OS endpoint in a confirmatory trial. Bristol Myers Squibb voluntarily withdrew Opdivo’s third-line SCLC indication at the end of 2020.