AVEO Oncology's Fotivda (tivozanib) Approved in the European Union, Norway, and Iceland for Treatment of Advanced Renal Cell Carcinoma.
M2 PHARMA-August 29, 2017-AVEO Oncology's Fotivda (tivozanib) Approved in the European Union, Norway, and Iceland for Treatment of Advanced Renal Cell Carcinoma
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- The European Commission has approved Cambridge, Massachusetts-based cancer therapeutics specialist AVEO Oncology (NASDAQ: AVEO) product Fotivda (tivozanib) for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland, the company said.
Tivozanib, an oral, once-daily, potent and highly-selective vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), is indicated for the first line treatment of adult patients with advanced RCC and for adult patients who are vascular endothelial growth factor receptor (VEGFR) and mTOR pathway inhibitor-naive following disease progression after one prior treatment with cytokine therapy for advanced RCC.
It is a potent, selective, and long half-life inhibitor of all three VEGFRs 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.
EUSA Pharma, a specialty pharmaceutical company with a focus on oncology and oncology supportive care, and the European licensee for tivozanib, has indicated that it intends to now work with the necessary health authorities to make tivozanib available to advanced RCC patients across Europe as quickly as possible.
The decision was primarily based on data from a global, open-label, randomized, multi-center Phase 3 trial (TIVO-1) which evaluated the efficacy and tolerability of tivozanib compared to a currently available comparator VEGFR-TKI treatment (sorafenib) in 517 patients with advanced RCC. Patients treated with tivozanib experienced superior PFS versus sorafenib.
AVEO Oncology is dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need. The company is focused on development and commercialization of its lead candidate tivozanib, and at progressing its pipeline of novel therapeutic candidates in cancer, cachexia, and pulmonary arterial hypertension.
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|Date:||Aug 29, 2017|
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