On November 15, 2017 EUSA Pharma and AVEO Oncology (NASDAQ:AVEO) reported the first commercial launch of FOTIVDA (tivozanib) with the initiation of product sales in Germany (Press release, AVEO, NOV 15, 2017, View Source;p=RssLanding&cat=news&id=2317048 [SID1234522076]). In the European Union, Norway and Iceland, tivozanib is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (aRCC) and for adult patients who are vascular endothelial growth factor receptor (VEGFR) and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for aRCC.i Tivozanib is an oral, once-daily, potent and highly-selective vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI). EUSA Pharma is the licensee for tivozanib in Europe, North and South Africa, Latin America and Australasia.
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Lee Morley, EUSA Pharma’s Chief Executive Officer said, "We are delighted that we have been able to grant access to FOTIVDA for patients in one of Europe’s key markets so soon after our regulatory approval. We look forward to working with physicians in Germany to ensure the profile and benefits of FOTIVDA are known and understood. We will of course continue to work with health authorities across all European markets to ensure early access to FOTIVDA as a therapeutic option in the ongoing fight against aRCC."
"The first-ever commercial launch of FOTIVDA is a tremendous accomplishment for AVEO, our partner EUSA Pharma, and, most importantly, patients with aRCC who now have access to a new and differentiated therapeutic option," said Michael Bailey, president and chief executive officer of AVEO. "Over the course of its development, FOTIVDA’s efficacy and tolerability profile among VEGF TKIs has been recognized by investigators as an important potential option for their patients, making this long-anticipated milestone a gratifying achievement. We continue to leverage this profile as we work towards exploring the full extent of FOTIVDA’s use in the emerging aRCC market. We also look forward to continuing to expand its availability in Europe, through our partner, EUSA, and potentially in North America, where we plan to file for FDA approval pending the results of our pivotal study, TIVO-3."
FOTIVDA was approved by the European Commission in August 2017. Approval was primarily based on data from a global, open-label, randomized, multi-center Phase 3 trial (TIVO-1)i,ii 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 (11.9 vs. 9.1 months in the overall population [HR, 0.797; 95% CI, 0.639 to 0.993; P =.042] and 12.7 vs. 9.1 months in treatment naïve patients [HR, 0.756; 95% CI, 0.580 to 0.985; P =.037]) versus sorafenib.ii There was also an improved side effect profile with tivozanib, with only 14% (versus 43% with sorafenib) requiring a dose reduction due to adverse events (AEs). In addition, fewer people on tivozanib experienced burdensome side effects, such as diarrhea (23% vs 33%) and hand-foot syndrome (14% vs 54%).ii
About RCC in Europe
RCC is the most common form of kidney cancer,iii which accounts for an estimated 49,000 deaths in Europe each year.iv It is expected to be one of the fastest increasing cancers over the next ten years.v Tyrosine Kinase Inhibitor (TKI) vascular endothelial growth factor (VEGF) inhibitors are the standard of care treatment for advanced RCC in Europe, however, patients on current treatments can often experience significant side effects.ii,vi
About Tivozanib (FOTIVDA)
Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma in the European Union plus Norway and Iceland. 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.i,ii Tivozanib has been investigated in several tumors types, including renal cell, colorectal and breast cancers.