Calithera Biosciences Gets Fast Track Designation for CB-839

Calithera Biosciences, a clinical stage biotechnology company developing novel cancer therapeutics, said Wednesday that the U.S. Food and Drug Administration 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 two 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 tumors including renal cell carcinoma, triple negative breast cancer, non-small cell lung cancer, and melanoma. The company said that it will be imitating a global randomized trial of CB-839 in combination with everolimus for the treatment of renal cell carcinoma in the second half of 2017.

By Bryan Smith