FDA recently fast-tracked approval of cabozantinib (Cabometyx, Exelixis, Inc.) to treat advanced renal cell carcinoma. Here are the top 5 facts to know about Cabometyx.
FDA recently fast-tracked approval of cabozantinib (Cabometyx, Exelixis, Inc.) to treat advanced renal cell carcinoma.
The drug, expected to be available this month, is indicated for the treatment of advanced renal cell carcinoma (RCC) in patients who have received prior anti-angiogenic therapy.
Related: FDA expands drug to treat NSCLC
Here are the top 5 facts to know about Cabometyx:
1. It will be available as an oral tablet in 20 mg, 40 mg, and 60 mg doses. The recommended dose is 60 mg daily.
2. Cabometyx is an oral antineoplastic agent that acts as a potent inhibitor of proinvasive receptor tyrosine kinases, which are involved in pathologic processes such as tumor growth, metastasis, and drug resistance. By inhibiting the signaling induced by these receptors, Cabometyx induces apoptosis of cancer cells and suppresses tumor growth.
3. During development, Cabometyx was granted fast track and breakthrough therapy designations by FDA, as early clinical evidence demonstrated potential clinical benefit in a serious disease.
4. FDA’s approval is based on the results of the phase 3 METEOR trial, which included 658 patients with advanced RCC who had failed at least 1 prior vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor (TKI) therapy. Patients were randomly assigned to receive either Cabometyx or everolimus, a standard of care therapy for second-line RCC. In the study, Cabometyx demonstrated clinically meaningful improvements in all 3 key efficacy parameters, including overall survival, progression-free survival and objective response rate
“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 with the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute. “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.”
5. Some of the most common adverse reactions associated with the drug include diarrhea, fatigue, nausea, decreased appetite, and hypertension.