29.11.2022 13:30:26
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Aravive Announces Fast Track Designation Of Batiraxcept - Quick Facts
(RTTNews) - Aravive, Inc. (ARAV) announced the FDA has granted Fast Track Designation to the company's lead program, batiraxcept, for treatment of patients with advanced or metastatic clear cell renal cell carcinoma who have progressed after 1 or 2 prior lines of systemic therapy that include both immuno-oncology-based and vascular endothelial growth factor tyrosine kinase inhibitor-based therapies. The Fast Track Designation was based on new data submitted to the agency from the P1b clear cell renal cell cancer study.
Gail McIntyre, CEO of Aravive, said: "Understanding the P1b ccRCC data has allowed us to identify the most appropriate patient population in which to evaluate batiraxcept in combination with cabozantinib and potentially the quickest path to approval in this population with an unmet medical need."
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