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FDA approves Cabometyx to treat advanced renal cell carcinoma

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The FDA approved cabozantinib to treat patients with advanced renal cell carcinoma who have received prior antiangiogenic therapy.

Cabozantinib (Cabometyx, Exelixis) is the first therapy to demonstrate improved OS, PFS and objective response rate in a phase 3 trial of patients with advanced renal cell carcinoma.

“With today’s announcement, patients with previously treated advanced kidney cancer now have a new option, the first and only approved product demonstrated to help patients live longer while also delaying the progression of their cancer,” Michael M. Morrissey, PhD, president and CEO of Exelixis, said in a release. “We are proud to bring new hope to this community, who are looking for more therapies that can help extend lives. Exelixis is committed to making Cabometyx available to patients in need within the next couple weeks.”

The approval was based on data from the phase 3 METEOR trial, which evaluated patients with advanced renal cell carcinoma who had received prior antiangiogenic therapy. Patients received 60 mg of oral cabozantinib once daily or 10 mg of oral everolimus once daily.

PFS served as the primary endpoint. Patients who received cabozantinib demonstrated a median PFS of 7.4 months compared with 3.8 months in the everolimus group (HR = 0.58; 95% CI, 0.45-0.74).

In addition, those who received cabozantinib demonstrated longer median OS (21.4 months vs. 16.5 months; HR = 0.66; 95% CI, 0.53-0.83) and a higher confirmed response rate (17% vs. 3%) compared with patients assigned everolimus.

The most common adverse events observed in patients who received cabozantinib included diarrhea, fatigue, nausea, decreased appetite, palmar–plantar erythrodysesthesia syndrome, hypertension, vomiting, weight decreased and constipation. Forty percent of patients experienced serious adverse events, the most common of which included abdominal pain, pleural effusion, diarrhea and nausea.

Sixty percent of patients who received cabozantinib required a dose reduction.

The recommended dose and schedule for cabozantinib is 60 mg orally daily.