AVEO Oncology Announces Regulatory Update for Tivozanib in Renal Cell Carcinoma
AVEO Pharmaceuticals, Inc. (AVEO)
Last aveo pharmaceuticals, inc. earnings: 3/16 04:05 pm
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Source: Business Wire
- NDA Filing Planned for 1Q20 for Relapsed/Refractory RCC –- Company Plans Final OS Analysis in 2Q20 - CAMBRIDGE, Mass.--(BUSINESS WIRE)--AVEO Oncology (NASDAQ: AVEO) today provided a regulatory update following a meeting with the U.S. Food and Drug Administration (FDA) to discuss results from the August 2019 overall survival (OS) analysis of the TIVO-3 trial and the Company’s proposal to proceed with a New Drug Application (NDA) for tivozanib.TIVO-3 is the Company’s Phase 3 randomized, controlled, multi-center, open-label study to compare tivozanib, the Company’s vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), to sorafenib in 350 subjects with highly refractory metastatic renal cell carcinoma (RCC). The TIVO-3 trial was designed to address the FDA’s concerns regarding the OS trend in the TIVO-1 trial. In the TIVO-1 trial, the Company’s initial RCC pivotal trial, the FDA found that the inconsistent progression free survival (PFS) and OS results an
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