FDA Approves Advanced Renal Cell Carcinoma Drug

The FDA today approved cabozantinib (Cabometyx) for patients who have advanced renal cell carcinoma and received prior anti-angiogenic therapy.

The approval was based on a randomized study in which all patients enrolled had advanced renal cell carcinoma and received prior anti-angiogenic therapy. Patients were randomized to receive either cabozantinib 60 mg orally once daily (N=330) or everolimus 10 mg orally once daily (N=328).

The primary endpoint of the study was progression-free survival in the first 375 randomized subjects.

Researchers found that median progression-free survival was 7.8 months in the cabozantinib cohort and 3.8 months in the everolimus cohort.

Median overall survival was 21.4 months in the cabozantinib cohort and 16.5 months in the everolimus cohort. A confirmed response rate of 17% was seen in the cabozantinib cohort and 3% in the everolimus cohort.

Safety was also evaluated in 331 patients in the cabozantinib cohort.

According to the study, the most common adverse effects were diarrhea, fatigue, nausea, decreased appetite, palmar-plantar erythrodysesthesia syndrome, hypertension, vomiting, weight decreased, and constipation.

Also, 60% of patients treated with cabozantinib had at least 1 dose reduction in the study. The current recommended dose is 60 mg daily.

Serious adverse events were reported in 40% of patients the most common being abdominal pain, pleural effusion, diarrhea, and nausea.

“The efficacy profile demonstrated by Cabometyx in the METEOR trial, now complemented by the overall survival benefit, is highly compelling,” Toni Choueiri, MD, Clinical Director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, said in a statement. “Cabometyx is distinct from other approved treatment options, as it targets multiple tyrosine kinases involved in the development of RCC, including MET, AXL and three VEGF receptors. At the same time, physicians are very familiar with this class of drug and how to use dose adjustments to balance safety and efficacy. The approval of Cabometyx is wonderful news for physicians who are looking for a new option for their previously treated patients with advanced kidney cancer.”