Trial Profile
A Randomized Controlled Phase 3 Study of Oral Pacritinib vERsus BeSt Available Therapy in PatIentS with Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post Essential Thrombocythemia Myelofibrosis
Status:
Discontinued
Phase of Trial:
Phase III
Latest Information Update: 28 Jul 2023
Price :
$35
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At a glance
- Drugs Pacritinib (Primary)
- Indications Myelofibrosis
- Focus Registrational; Therapeutic Use
- Acronyms PERSIST-1
- Sponsors Cell Therapeutics; CTI BioPharma
- 15 Jun 2023 Results from PERSIST-1 and PERSIST-2, assessing consistent efficacy of Pacritinib for spleen and symptom response in patients with MF regardless of blood counts , presented at the 28th Congress of the European Haematology Association
- 06 Jun 2023 Results assessing data on spleen and symptom benefit in pacritinib-treated patients across the cytopenic spectrum, stratified by both baseline platelet (PLT) count and hemoglobin (HB) level in PERSIST-1 and PERSIST-2 studies , presented at the 59th Annual Meeting of the American Society of Clinical Oncology.
- 30 Nov 2021 According to a CTI BioPharma media release, the US FDA has extended the review period for the NDA for pacritinib for the treatment of adult patients with intermediate or high risk primary or secondary (post polycythemia vera or post-essential thrombocythemia) myelofibrosis with a baseline platelet count of less than 50 x 109/L, based on data from Phase 3 PERSIST-2 and PERSIST-1 and PACIFICA trials. The Prescription Drug User Fee Act action date has been extended to 28 Feb 2022.