Trial Profile
An Extension Treatment Protocol for Subjects Who Have Participated in a Phase 3 Study of Tivozanib vs. Sorafenib in Renal Cell Carcinoma (Protocol AV-951-09-301)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 04 Apr 2022
Price :
$35
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At a glance
- Drugs Tivozanib (Primary) ; Sorafenib
- Indications Renal cell carcinoma
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors Astellas Pharma; AVEO Oncology
- 01 Jun 2020 According to an AVEO Oncology media release, the U.S. Food and Drug Administration (FDA) accepted for filing its New Drug Application (NDA) seeking approval for tivozanib. The FDA has assigned the application standard review and a Prescription Drug User Fee Act target action date of March 31, 2021. The FDA also indicated that they do not currently plan on convening an Oncologic Drug Advisory Committee (ODAC) to discuss the application.
- 31 Mar 2020 According to an AVEO Oncology media release, the company has submitted a New Drug Application (NDA) to the U.S. FDA for tivozanib, as a treatment for relapsed or refractory renal cell carcinoma (RCC). The NDA submission is based on the pivotal active comparator-controlled Phase 3 study (TIVO-3 ).The application is supported by three additional trials (a supportive Phase 3 study: TIVO-1, two Phase 2 studies, Study 902 and Study 201).
- 21 Mar 2018 Results (n=161) published in an AVEO Oncology Media Release