Recurrence of treatment or breakthrough for kidney cell carcinoma: FDA approves Tivozanib's NDA
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Last Update: 2020-06-05
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Source: Internet
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Author: User
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Pharmaceutical company AVEO announced today that the U.SFDA has approved Tivozanib's new drug application (NDA) for the treatment of recurrent refractory renal cell carcinoma (RCC), the company's next generation of endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKI)In preclinical models, Tivozanib significantly reduced the production of regulatory T-cells and demonstrated synergy with nivolumab (anti-PD-1 antibody) in Phase II studiesA variety of tumor types have been studied for Tivozanib treatment, including renal cell carcinoma, hepatocellular carcinoma, colorectal cancer, ovarian cancer and breast cancer"FDA approval is another important milestone for AVEO, and we look forward to working closely with the FDA in the coming months," said Michael Bailey, President and CEO of AVEOThe FDA approval is based on the latest results from the critical Phase III trial (TIVO-3 study), which compared the effectiveness and safety of tivozanib with sorafenib in line 3 and 4 RCC treatmentsThe Phase III trial (TIVO-1 study) also compared the effectiveness and safety of tivozanib and sorafenib in line 1 RCC therapy
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