Positive opinion for tivozanib for the first-line treatment of advanced renal cell carcinoma in the EU

EUSA Pharma has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorisation of Fotivda (tivozanib) for the management of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland.

If approved, it will be indicated for the first-line treatment of adult patients with advanced RCC and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.¹

RCC is the most common form of kidney cancer,² which accounts for an estimated 49,000 deaths in Europe each year.³ It is expected to be one of the fastest increasing cancers over the next ten years.⁴ Vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKIs) are currently the gold standard first-line treatment for advanced RCC in Europe, however, patients on existing treatments can often experience significant side effects.^5,6

The CHMP’s recommendation is based on data from the global, open-label, randomised, multi-centre Phase III trial (TiVO-1)^1,5 which evaluated the efficacy and tolerability of tivozanib compared to a currently available comparator VEGFR-TKI treatment (sorafenib) in the treatment of over 500 patients with advanced RCC. The trial met its primary endpoint demonstrating the longest median progression-free survival (PFS) seen with a VEGFR-TKI in a first-line phase III clinical study in 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 =0.042] and 12.7 vs. 9.1 months in treatment-naïve patients [HR, 0.756; 95% CI, 0.580 to 0.985; P =0.037]) versus sorafenib.^1,5 There was also an improved side effect profile with tivozanib, meaning 86% of patients were able to remain on full dose (versus 57% with sorafenib, P = <0.001), with only 14% (versus 43% with sorafenib) requiring a dose reduction due to adverse events (AEs). In addition, fewer people on tivozanib experienced the burdensome side effects, commonly associated with other VEGFR-TKIs, such as diarrhoea (23% vs 33%), and hand-foot syndrome (14% vs 54%).⁵

Dr Bernard Escudier, Medical Oncologist and member of the Genitourinary Tumour Board of Gustave Roussy, France, commented “This is excellent news for patients with metastatic RCC. Outcomes in this disease have greatly improved with the introduction of targeted therapies, meaning that patients are living for longer, although currently available therapies can be associated with burdensome toxicities. We are still in need of effective and well tolerated new treatments in metastatic RCC and thus, tivozanib will be a welcomed addition. We also look forward to continuing our investigations of potential combination approaches with other therapeutic agents.

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