AVEO Oncology has recently announced that the filing of its NDA’s (New Drug Application) for tivozanib has been approved by the U.S. FDA (Food and Drug Administration). Tivozanib is the next-gen VEGFR- (vascular endothelial growth factor receptor) TKI (tyrosine kinase inhibitor). It is used for the treatment of refractory or relapsed RCC (renal cell carcinoma).
The U.S. FDA has assigned the standard review of the NDA and a PDUFA (Prescription Drug User Fee Act) target action on 31st March 2021. The agency also indicated its plan not to set up an ODAC (Oncologic Drug Advisory Committee) for discussing the application.
According to Michael Bailey, AVEO’s chief executive officer and president, the approval of the NDA filing by the FDA indicates another breakthrough for the company. It aims at supporting the RCC patients with a significant treatment options in the event that their condition has relapsed or turned refractory to several therapy lines. It is also planning to continuously gain assistance from the FDA during the review of the NDA for tivozanib. It is also critically and objectively evaluating the commercial attractiveness of the new drug to potentially launch tivozanib, depending on the approval of the regulatory authority.
The filing of the NDA is based on the pivotal Phase 3 trial of TIVO-3 conducted by the company. In the trial, tivozanib was compared to sorafenib in the 3rd and 4th line RCC. It includes the results that were presented recently at the ASCO (American Society of Clinical Oncology) 2020 Virtual Scientific Program. The recently filed application is supported by 3 additional trials, namely a comparator-controlled Phase 3 trial, TIVO-1, which compares tivozanib to sorafenib in the 1st line renal cell carcinoma, and two Phase 2 trials. These two trials are Study 902, which is a crossover, open-label clinical study of tivozanib for the sorafenib-progressed patients in TIVO-1, and Study 201, which is a study controlled by placebo in 1st line RCC. Data from nearly 1,000 clinical study subjects in total have supported the application.