Trial Profile
A Phase 3, Randomized, Double-blind Active-controlled Study Evaluating Momelotinib vs. Ruxolitinib in Subjects With Primary Myelofibrosis (PMF) or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 06 Feb 2024
Price :
$35
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At a glance
- Drugs Momelotinib (Primary) ; Ruxolitinib
- Indications Anaemia; Myelofibrosis
- Focus Registrational; Therapeutic Use
- Acronyms Simplify 1
- Sponsors Gilead Sciences; Sierra Oncology
- 30 Jan 2024 According to GlaxoSmithKline media release,company announces that health canada has accepted into review the New Drug Submission(NDS) for momelotinib, follows that of the Ministry of Health, Labour and Welfare (WHLW) in Japan and approval by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).The NDS is based on key phase III trials SIMPLIFY-1 and MOMENTUM
- 12 Dec 2023 Results of pooled analysis from SIMPLIFY-1 and SIMPLIFY-2 , applying time without transfusion reliance (TWiTR) analyses, integrating transfusion-dependent (TD) status and OS, to further characterize the benefits of MMB on survival quality.presented at the 65th American Society of Hematology Annual Meeting and Exposition
- 12 Dec 2023 Results demonstrating the prognostic influence of RBC transfusion status and other covariates on overall survival SIMPLIFY-1 (S1), SIMPLIFY-2 (S2), and MOMENTUM studies presented at the 65th American Society of Hematology Annual Meeting and Exposition