Posted by Michael Wonder on 18 Apr 2018
Calithera Biosciences announces FDA fast track designation granted to CB-839 in combination with cabozantinib for treatment of patients with advanced renal cell carcinoma
18 April 2018 - Randomised CANTATA trial open for enrolment.
Calithera Biosciences today announced that the U.S. FDA has granted fast track designation to CB-839 in combination with cabozantinib for the treatment of patients with metastatic renal cell carcinoma 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 and ipilimumab.
CB-839 is a first-in-class, oral, selective, potent inhibitor of glutaminase being evaluated in the 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 enrolment.
