Trial Profile
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Nirogacestat Versus Placebo in Adult Patients With Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF)
Status:
Active, no longer recruiting
Phase of Trial:
Phase III
Latest Information Update: 05 Mar 2024
Price :
$35
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At a glance
- Drugs Nirogacestat (Primary)
- Indications Fibroma
- Focus Registrational; Therapeutic Use
- Acronyms DeFi
- Sponsors SpringWorks Therapeutics
- 29 Feb 2024 According to SpringWorks Therapeutics media release, company announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for nirogacestat for the treatment of adults with desmoid tumors based on the results of this study.
- 08 Jan 2024 According to SpringWorks Therapeutics media release, company is planning to submit Marketing Authorisation Application (MAA) for nirogacestat for the treatment of adult patients with desmoid tumors to the European Medicines Agency (EMA) in the first half of 2024.
- 27 Nov 2023 According to a SpringWorks Therapeutics media release, SpringWorks will host a conference call and webcast to discuss the FDA approval of OGSIVEO on Tuesday, November 28, 2023.