CB-839 in Combination With Cabozantinib for Advanced RCC Granted FDA Fast Track Designation

On April 18, Calithera Biosciences, Inc, announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to CB-839 in combination with cabozantinib (Cabometyx) for the treatment of patients with metastatic renal cell carcinoma (RCC) who have received one or two prior lines of therapy, including at least one vascular endothelial growth factor tyrosine kinase inhibitor or the combination of nivolumab (Opdivo) and ipilimumab (Yervoy). 

CB-839 is a first-in-class, oral, selective, potent inhibitor of glutaminase being evaluated in the phase II CANTATA trial. The trial is a randomized double-blind clinical study of cabozantinib in combination with CB-839 or placebo in 298 patients with clear cell renal cell carcinoma. The primary endpoint is progression-free survival, and the global study is open for enrollment.

CB-839’s onco-metabolism activity takes advantage of the unique metabolic requirements of tumor cells and cancer-fighting immune cells, such as cytotoxic T cells. It is currently being evaluated in phase II clinical trials in multiple tumor types in combination with standard-of-care agents.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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