Calithera Biosciences today announced that the U.S. FDA has granted fast track designation to CB-839 in combination with everolimus, for the treatment of patients with metastatic renal cell carcinoma who have received 2 or more prior lines of therapy.
CB-839 is a first-in-class, oral, selective, potent inhibitor of glutaminase being evaluated in Phase 1/2 clinical trials for the treatment of solid tumours including renal cell carcinoma, triple negative breast cancer, non-small cell lung cancer, and melanoma.