Calithera's Kidney Cancer Candidate Gets Fast Track Status
Zacks Investment Research | Apr 19, 2018 08:55AM ET
Calithera Biosciences, Inc. (NASDAQ:CALA) announced that the FDA has granted Fast Track designation to its lead candidate, CB-839. The candidate is being developed in combination with Exelixis, Inc.’s (NASDAQ:EXEL) Cabometyx (cabozantinib) for the treatment of metastatic kidney cancer.
The FDA grants a fast track designation to expedite a candidate’s development and review, which treats serious and unmet medical conditions. With this designation, a candidate is expected to be granted a priority review once it files a new drug application.
Calithera’s shares have underperformed the industry so far this year. The stock has lost 25.7% compared with the industry’s fall of 0.6%.
Calithera’s CB-839, a selective, potent inhibitor of glutaminase, is being evaluated in a phase II study – CANTATA – in combination with Cabometyx in clear cell renal cell carcinoma (“RCC”) in patients previously treated with at least one vascular endothelial growth factor tyrosine kinase inhibitor or the combination of Bristol-Myers’ (NYSE:BMY) Opdivo (nivolumab) and Yervoy (ipilimumab).
The study is currently enrolling patients and the primary endpoint is improved progression free survival.
Per the press release, there are a number of therapies approved for RCC. However, there still remains a significant unmet need in advanced stage patients who have failed prior systemic therapy.
Kidney cancer is among the top 10 common cancer types globally, per the American Cancer Society. The organization predicts that an estimated 65,340 new patients will be diagnosed with the disease in the United States in 2018. Moreover, 14,970 deaths will be caused due to this cancer.
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