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# Calithera Bio Gains Fast Track for Carcinoma Drug
- URL: https://www.fdaweb.com/calithera-bio-gains-fast-track-for-carcinoma-drug/
- Published: 2018-04-18T12:00:00.000Z
- Updated: 2026-09-14T23:59:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141253

FDA has granted fast track status to Calithera Biosciences for CB-839 and its use in combination with cabozantinib for treating 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. Calithera says CB-839 is a first-in-class, oral, selective, potent inhibitor of glutaminase being evaluated in the CANTATA trial. The randomized, placebo-controlled clinical study involves 298 patients with clear cell renal cell carcinoma. The primary endpoint is progression free survival. “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,” the company says.