EUSA Pharma (EUSA) welcomes the news that FOTIVDA® (tivozanib) is expected to be included in the upcoming European Society of Medical Oncology (ESMO) clinical practice guidelines for advanced renal cell carcinoma (aRCC), anticipated to be published at the end of this year.
The outline of the new proposed guidelines was presented on 19th October at the annual ESMO 2018 Congress in Munich, Germany, and indicated that tivozanib will be included as a first-line treatment recommendation for aRCC clear cell histology patients. The update will position tivozanib as a treatment standard for good (or favourable) risk patients with a Class IIa recommendation, and a treatment option for intermediate risk patients with a Class IIb recommendation.
The indication of inclusion of tivozanib in the ESMO guidelines follows the grant of a European Commission (EC) licence in August 2017 for this oral, once-daily,a potent selective vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKI) as first-line treatment of adult patients with aRCC.
The authorization within the European Union (EU) was based on evidence from the global, open-label, randomised, multi-centre Phase III trial TiVO-1, which showed that aRCC patients receiving tivozanib experienced superior progression free survival and an improved side effect profile compared to those receiving another VEGFR-TKI, sorafenib.
"EUSA Pharma are pleased to receive this indication of the inclusion of tivozanib in such important European guidelines reflecting both its EU authorization and the potential patient benefits as a result of its efficacy and tolerability profile," said Lee Morley, Chief Executive, EUSA Pharma. "We continue to progress the launch of FOTIVDA across the EU in line with the indication as a monotherapy in the first-line setting treatment of advanced renal cell carcinoma."
Kidney cancer is the seventh most common cancer in Europe and the 14th worldwide, with over 400,000 new cases in 2018. RCC is the most common form of kidney cancer, accounting for 80% of cases and there are an estimated 49,000 deaths from kidney cancer each year in Europe, 143,000 globally. Kidney cancer is expected to be one of the fastest increasing cancers over the next ten years as a result of Europe's ageing population, with smoking and a rise in obesity also playing a part.