Drug Overview
Fotivda (tivozanib; AVEO Oncology/EUSA Pharma/Kyowa Hakko Kirin) is an oral tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 1 (VEGFR-1), VEGFR-2, and VEGFR-3. Inhibition of VEGF signaling in order to prevent angiogenesis is a well-established strategy across many tumor types; however, Fotivda’s potency, selectivity, and long half-life are hypothesized to improve the drug’s efficacy and safety in comparison to its predecessors.
Based on data from the TIVO-1 clinical trial (ClinicalTrials.gov identifier: NCT01030783), Fotivda was approved in the EU in 2017 for the treatment of advanced renal cell carcinoma (RCC) patients who have received no prior therapy, or who are VEGFR and mammalian target of rapamycin (mTOR) pathway inhibitor-naïve, but whose disease has progressed after one prior treatment with cytokine therapy. In the US, the initial New Drug Application, also based on the TIVO-1 clinical trial data, was met with a complete response letter from the US Food and Drug Administration (FDA). Following this, AVEO Oncology conducted the TIVO-3 trial investigating Fotivda’s use in the third and fourth line, and the company has indicated it intends to file with the FDA based on combined data from TIVO-1 and TIVO-3. However, based on the interim data from TIVO-3 and the history of Fotivda with the FDA, the author does not expect Fotivda to launch in the US at this time, and the drug’s absence from the US market will significantly restrict its future sales.
Analyst Outlook
Based on data from the TIVO-1 clinical trial (ClinicalTrials.gov identifier: NCT01030783), Fotivda (tivozanib; AVEO Oncology/EUSA Pharma/Kyowa Hakko Kirin) was approved in the EU in 2017 for the treatment of advanced renal cell carcinoma (RCC) patients who have received no prior therapy, or who are vascular endothelial growth factor receptor (VEGFR) and mammalian target of rapamycin (mTOR) pathway inhibitor-naïve, but whose disease has progressed after one prior treatment with cytokine therapy. In the US, the initial New Drug Application (NDA), also based on the TIVO-1 clinical trial data, was met with a complete response letter (CRL) from the US Food and Drug Administration (FDA). Following this, AVEO Oncology conducted the TIVO-3 trial investigating Fotivda’s use in the third and fourth line, and the company has indicated it intends to file with the FDA based on combined data from TIVO-1 and TIVO-3 (AVEO press release, 2018). However, based on the interim data from TIVO-3 and the history of Fotivda with the FDA, the author does not expect Fotivda to launch in the US at this time, and the drug’s absence from the US market will significantly restrict its future sales.
Fotivda (tivozanib; AVEO Oncology/EUSA Pharma/Kyowa Hakko Kirin) is an oral tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 1 (VEGFR-1), VEGFR-2, and VEGFR-3. Inhibition of VEGF signaling in order to prevent angiogenesis is a well-established strategy across many tumor types; however, Fotivda’s potency, selectivity, and long half-life are hypothesized to improve the drug’s efficacy and safety in comparison to its predecessors.
Based on data from the TIVO-1 clinical trial (ClinicalTrials.gov identifier: NCT01030783), Fotivda was approved in the EU in 2017 for the treatment of advanced renal cell carcinoma (RCC) patients who have received no prior therapy, or who are VEGFR and mammalian target of rapamycin (mTOR) pathway inhibitor-naïve, but whose disease has progressed after one prior treatment with cytokine therapy. In the US, the initial New Drug Application, also based on the TIVO-1 clinical trial data, was met with a complete response letter from the US Food and Drug Administration (FDA). Following this, AVEO Oncology conducted the TIVO-3 trial investigating Fotivda’s use in the third and fourth line, and the company has indicated it intends to file with the FDA based on combined data from TIVO-1 and TIVO-3. However, based on the interim data from TIVO-3 and the history of Fotivda with the FDA, the author does not expect Fotivda to launch in the US at this time, and the drug’s absence from the US market will significantly restrict its future sales.
Analyst Outlook
Based on data from the TIVO-1 clinical trial (ClinicalTrials.gov identifier: NCT01030783), Fotivda (tivozanib; AVEO Oncology/EUSA Pharma/Kyowa Hakko Kirin) was approved in the EU in 2017 for the treatment of advanced renal cell carcinoma (RCC) patients who have received no prior therapy, or who are vascular endothelial growth factor receptor (VEGFR) and mammalian target of rapamycin (mTOR) pathway inhibitor-naïve, but whose disease has progressed after one prior treatment with cytokine therapy. In the US, the initial New Drug Application (NDA), also based on the TIVO-1 clinical trial data, was met with a complete response letter (CRL) from the US Food and Drug Administration (FDA). Following this, AVEO Oncology conducted the TIVO-3 trial investigating Fotivda’s use in the third and fourth line, and the company has indicated it intends to file with the FDA based on combined data from TIVO-1 and TIVO-3 (AVEO press release, 2018). However, based on the interim data from TIVO-3 and the history of Fotivda with the FDA, the author does not expect Fotivda to launch in the US at this time, and the drug’s absence from the US market will significantly restrict its future sales.
Table of Contents
OVERVIEW
LIST OF FIGURES
LIST OF TABLES
