On May 19, 2017 AVEO Oncology (NASDAQ:AVEO) reported its European licensee for tivozanib, EUSA Pharma, has completed an oral explanation to the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), as part of the Marketing Authorization Application (MAA) review process for tivozanib as a treatment for patients with first-line renal cell carcinoma (RCC) (Press release, AVEO, MAY 19, 2017, View Source;p=RssLanding&cat=news&id=2274241 [SID1234519231]). It is expected that with the oral explanation complete, the CHMP will proceed to an opinion which they will submit to the European Commission (EC), which has the authority to approve medicines for use in the 28 countries in the European Union. The opinion is expected to be announced at a future CHMP meeting.
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"We are pleased that the file continues to progress through the CHMP review process with EUSA having completed an oral explanation for tivozanib," said Michael Bailey, president and chief executive officer of AVEO. "We believe tivozanib’s unique tolerability profile, together with the longest progression free survival from a Phase 3 first line RCC study, demonstrates its potential to enhance treatment options for RCC patients."
RCC is the most common form of kidney cancer,i which accounts for an estimated 49,000 deaths in Europe each year.ii It is expected to be one of the fastest increasing cancers over the next ten years.iii Tyrosine Kinase Inhibitor (TKI) vascular endothelial growth factor (VEGF) inhibitors are the gold standard treatment for advanced RCC in Europe, however, patients on current treatments can often experience significant side effects.iv,v
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.