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Cabozantinib Granted Regular Approval by FDA for First-Line Treatment of Advanced Kidney Cancer

By: Sarah Jackson
Posted: Friday, December 22, 2017

On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to cabozantinib (Cabometyx) for treatment of patients with advanced renal cell carcinoma. The FDA previously approved cabozantinib in 2016 for treatment of patients with advanced renal cell carcinoma who have received prior antiangiogenic therapy, but this most recent approval provides for treatment in the first-line setting.

This approval was based on data from CABOSUN ( identifier NCT01835158), a randomized, open-label phase II multicenter study in 157 patients with intermediate- and poor-risk previously untreated renal cell carcinoma. Patients received cabozantinib orally or sunitinib orally on a daily basis until disease progression or unacceptable toxicity. Estimated median progression-free survival for patients taking cabozantinib was 8.6 months compared with 5.3 months for patients taking sunitinib.

The most common adverse reactions in the cabozantinib clinical program were diarrhea, fatigue, nausea, decreased appetite, hypertension, palmar-plantar erythrodysesthesia, weight loss, vomiting, dysgeusia, and stomatitis. The most frequent grade 3/4 adverse reactions (≥ 5%) associated with cabozantinib in the CABOSUN trial were hypertension, diarrhea, hyponatremia, hypophosphatemia, palmar-plantar erythrodysesthesia, fatigue, alanine transaminase increased, decreased appetite, stomatitis, pain, hypotension, and syncope.

The recommended dose of cabozantinib is 60 mg orally, once daily.