Cabozantinib (Cabometyx) was previously granted priority review as a therapy for advanced renal cell carcinoma.
Yesterday, the FDA granted approval to cabozantinib (Cabometyx) as a first-line treatment for patients with advanced renal cell carcinoma (RCC), according to a press release.
In 2016, the FDA approved cabozantinib to treat patients with advanced RCC who were previously treated with anti-angiogenic therapy.
The new approval was based on positive findings from the CABOSUN phase 2 clinical trial, which included 157 patients with moderate- and poor-risk untreated RCC. Patients were randomized to receive cabozantinib 60-mg daily or sunitinib 50-mg daily until progression or toxicity.
The mean progression-free survival for patients treated with cabozantinib was 8.6 months compared with 5.3 months for sunitinib-treated patients, according to the FDA.
The most common adverse reactions included diarrhea, fatigue, nausea, decreased appetite, hypertension, palmar-plantar erythrodysesthesia (PPE), weight loss, vomiting, dysgeusia, and stomatitis.
The most severe reactions among patients with RCC were hypertension, diarrhea, hyponatremia, hypophosphatemia, PPE, fatigue, ALT increase, decreased appetite, stomatitis, pain, hypotension, and syncope, according to the release.
The FDA also previously granted approval to cabozantinib for patients with medullary thyroid cancer; however, the drug is marketed as Cometriq for this indication, according to the release. The FDA advised that Cometriq and Cabometyx are different formulations of the drug and cannot be interchanged.