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FDA grants fast track designation to CB-839 for metastatic kidney cancer
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The FDA granted fast track designation to CB-839 for use in combination with everolimus for the treatment of patients with metastatic renal cell carcinoma who received at least two prior lines of therapy, according to the drug’s manufacturer.
An ongoing phase 1/phase 2 study is designed to evaluate CB-839 (Calithera Biosciences) — a first-in-class, oral, selective, potent glutaminase inhibitor — in combination with everolimus (Afinitor, Novartis). The trial includes patients with 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,” Susan Molineaux, PhD, president and CEO of Calithera, said in a company-issued press release.
The company plans to initiate a global, randomized trial of the combination this year, Molineauz added.