FDA approves Exelixis’ Cabometyx

SILVER SPRING, Md. — The Food and Drug Administration has approved Exelixis’ Cabometyx (cabozantinib) tablets, the company announced this week. Cabometyx is indicated to treat patients with advanced renal cell carcinoma who have previously received anti-angiogenic treatment. 

 

The drug was granted Fast Track and Breakthrough Therapy designations, and the company said it’s the first to demonstrate clinically meaningful improvements in a phase three trial for overall survival, progression free survival and objective response rate. 

 

“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,” Exelixis president and CEO Michael Morrissey said. “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 drug is available in 20-, 40- and 60-mg dosage strengths.