EUSA Pharma (EUSA), a specialty pharmaceutical company with a focus on oncology and oncology supportive care, 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, tivozanib 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.
RCC is the most common form of kidney cancer, accounting for an estimated 49,000 deaths in Europe each year. It is expected to be one of the fastest increasing cancers over the next 10 years.
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.
The CHMP’s recommendation is based on data from the global, open-label, randomised, multi-centre Phase III trial (TiVO-1), 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) and 12.7 vs. 9.1 months in treatment-naïve patients versus sorafenib.
Dr Bernard Escudier, Medical Oncologist and member of the Genitourinary Tumour Board of Gustave Roussy, France, said: “This is excellent news for patients with metastatic RCC. We are still in need of effective and well tolerated new treatments in metastatic RCC and thus, tivozanib will be a welcomed addition.”