The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CB-839 in combination with afinitor® (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 tumors including renal cell carcinoma, triple negative breast cancer, non-small cell lung cancer, and melanoma.
“We are pleased that CB-839 has been granted Fast Track designation, demonstrating the FDA’s commitment to facilitate the development and expedite the review of our glutaminase inhibitor as an important new therapy for patients with relapsed renal cell carcinoma,” said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. “We look forward to initiating a global randomized trial of CB-839 in combination with afinitor® for the treatment of renal cell carcinoma in the second half of 2017.”
The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drugs and biologics, to treat serious or life threatening conditions, and to fill an unmet medical need. Specifically, Fast Track designation facilitates frequent interactions with the FDA review team, including meetings to discuss all aspects of development to support approval, and also provides the opportunity to submit sections of an NDA on a rolling basis as data become available.
About Calithera Biosciences
Calithera Biosciences, Inc. is a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer. Calithera’s lead product candidate, CB-839, is an inhibitor of glutaminase. CB-839 takes advantage of the pronounced dependency many cancers have on the nutrient glutamine for growth and survival. It is currently being evaluated in Phase 1/2 clinical trials in combination with standard of care agents. CB-1158 is an investigational immuno-oncology metabolic checkpoint inhibitor designed to target arginase, a critical immunosuppressive enzyme responsible for T-cell suppression by myeloid-derived suppressor cells (MDSCs). Arginase depletes arginine, a nutrient that is critical for the activation, growth and survival of the body’s cancer-fighting immune cells, known as cytotoxic T-cells. CB-1158 is being developed in collaboration with Incyte Corporation and is currently in a Phase I clinical trial.
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