FDA Approves Advanced Renal Cell Carcinoma Treatment – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889
Officials with the FDA recently approved cabozantinib (Cabometyx) for the first-line treatment of 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.