FDA Approves Cabozantinib for Advanced Renal Cell Carcinoma
Cabozantinib (Cabometyx) has recieved FDA approval for treatment of patients with advanced RCC who have received prior antiangiogenic therapy.
The U.S. Food and Drug Administration has approved cabozantinib (Cabometyx) for the treatment of patients with advanced renal cell carcinoma who have received prior antiangiogenic therapy.1
“The efficacy profile demonstrated by Cabometyx in the METEOR trial, now complemented by the overall survival benefit, is highly compelling,” said Toni Choueiri, MD, clinical director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute in Boston, MA.
Approval was based on findings from the phase 3 METEOR trial, which compared cabozantinib 60 mg once daily with everolimus 10 mg once daily in 658 patients with advanced renal cell carcinoma who received prior antiangiogenic therapy.
Results showed that median progression-free survival among the first 375 randomized patients was 7.4 months with cabozantinib vs 3.8 months with everolimus (HR, 0.58; 95% CI, 0.45 - 0.74; P < .0001). Median overall survival in the intent-to-treat population was 21.4 months and 16.5 months, respectively (HR, 0.66; 95% CI, 0.53 - 0.83; P =. 0003). The confirmed response rate was 17% (95% CI, 13 - 22) for cabozantinib and 3% (95% CI, 2 - 6) for everolimus.
The most frequently reported adverse events were diarrhea, fatigue, nausea, decreased appetite, palmar-plantar erythrodysesthesia syndrome (PPES), hypertension, vomiting, decreased weight, and constipation. Six out of 10 patients treated with cabozantinib required at least 1 dose reduction and 40% of patients reported serious adverse events.
RELATED: FDA Grants Breakthrough Therapy Designation to Cabozantinib for Renal Cell Carcinoma
The recommended dose and schedule for cabozantinib in patients with kidney cancer is 60 mg orally once daily. Clinicians should instruct their patients not to eat for at least 2 hours before and at least 1 hour after taking cabozantinib.2
“Cabometyx is distinct from other approved treatment options, as it targets multiple tyrosine kinases involved in the development of RCC, including MET, AXL and 3 VEGF [vascular endothelial growth factor] receptors,” said Dr Choueiri. “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,” Dr Choueiri said.
- Exelixis announces FDA approval of Cabometyx™ (cabozantinib) tablets for patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy [news release]. South San Francisco, CA: Exelixis, Inc; April 25, 2016. http://www.exelixis.com/investors-media/press-releases. Accessed April 25, 2016.
- Cabometyx (cabozantinib) [prescribing information]. South San Francisco, CA: Exelixis, Inc; April 25, 2016. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208692s000lbl.pdf.