Renal Cell Carcinoma Treatment Approved

The FDA has approved Exelixis’ cabozantinib (Cabometryx) as a treatment for advanced renal cell carcinoma patients who have received antiangiogenic therapy.

“With [this] 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,” said Michael Morrissey, president and CEO of Exelixis, in a press 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.”

In a phase 3 trial, Cabometyx is the first drug to demonstrate clinically meaningful improvements in 3 key efficacy areas: overall survival, progression-free survival, and objective response rate.

Compared with everolimus, Cabometyx was associated with a 42% reduction in the rate of disease progression or death.

Median progression-free survival for the intervention treatment was 7.4 months compared with 3.8 months for patients taking everolimus.

“The efficacy profile demonstrated by Cabometyx in the METEOR trial, now complemented by the overall survival benefit, is highly compelling,” said Toni Choueiri, clinical director at the Lank Center for Genitourinary Oncology at the Dana-Farber Cancer Institute, in a press release.

The most common adverse reactions observed in patients using Cabometryx included diarrhea, fatigue, nausea, and decreased appetite.

Renal cell carcinoma is the most common form of kidney cancer in adults.