AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) announced recently that the European Commission (EC) has approved FOTIVDA® (tivozanib) to be used for the treatment of adults who are diagnosed with the Advanced Renal Cell Carcinoma (RCC) within the European Union (EU), together with Norway, and Iceland regions.
Tivozanib is specified for adult patients suffering from the advanced RCC and in adult patients with Vascular Endothelial Growth Factor Receptor (VEGFR) in the first-line treatment and mTOR passageway inhibitor-naïve after the disease has progressed to another level following the prior treatment with cytokine therapy which also cures advanced RCC.
According to Dr. Bernard Escudier, the Medical Oncologist in France, the great news is a relief to many patients with advanced RCC. With the new treatment, the disease will be easily managed and the patients will live longer. However, more effective and well-tolerated treatments are needed for metastatic RCC and hence the new tivozanib is just the beginning of the numerous therapies that would be introduced in the near future.
The approval of the FOTIVDA® (tivozanib) from the EC followed the suggestions made by the Committee for Medical Products for Human Use (CHMP) which was based on the data collected from the global and randomized center Phase 3 trial (TIVO-1). Both the efficacy and tolerability of the new treatment was evaluated in comparison to the existing treatments in 517 sampled patients with advanced RCC.
The patients who participated in the study reported superior improvements after being treated with tivozanib compared to those patients that used the currently available treatments. The patients also experienced fewer side effects when treated with tivozanib. The company together with EUSA Pharma intends to work together with the relevant health authorities to ensure the tivozanib treatment is accessible to all patients of advanced RCC across the whole region of Europe as soon as possible.
According to Michael Bailey, the president and CEO of AVEO, the availability of tivozanib across the region is the first step to making the treatment available to patients in Europe and with the approval from the EC, the treatment shall be extended to other countries across the world.
