On April 13, 2017 AVEO Oncology (NASDAQ: AVEO) reported that its European licensee for tivozanib, EUSA Pharma, has submitted responses to the European Medicines Agency (EMA) Day 180 List of Outstanding Issues (LOI) related to the Marketing Authorization Application (MAA) for tivozanib as a first-line treatment for renal cell carcinoma (Press release, AVEO, APR 13, 2017, View Source [SID1234518533]). With submission of the response complete, EUSA remains tentatively scheduled to provide an oral explanation to the EMA’s Committee for Medicinal Products for Human Use (CHMP) at its May 2017 meeting. Schedule your 30 min Free 1stOncology Demo! "Responding to the Day 180 List of Outstanding Issues is another important step in the tivozanib MAA, and we continue to work with EUSA Pharma in their effort to seek regulatory approval for tivozanib in Europe," said Michael Bailey, president and chief executive officer of AVEO. "This includes supporting EUSA as they proceed toward a planned oral explanation to the CHMP in May, while at the same time we continue to advance our registration strategy for tivozanib in the United States. We look forward to providing updates on these dual paths as we complete the final phase of the European approval process and work toward our goal of full enrollment in our U.S. registration-directed TIVO-3 study."
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As previously announced, the Day 180 LOI signified that the MAA is not approvable at that time, and outlines outstanding deficiencies, which are then required to be satisfactorily addressed in an oral explanation and/or in writing prior to a final application decision.
About Tivozanib
Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib has been investigated in several tumors types, including renal cell, colorectal and breast cancers.