Vonjo FDA Approval History
Last updated by Judith Stewart, BPharm on March 3, 2022.
FDA Approved: Yes (First approved February 28, 2022)
Brand name: Vonjo
Generic name: pacritinib
Dosage form: Capsules
Company: CTI BioPharma Corp.
Treatment for: Myelofibrosis
Vonjo (pacritinib) is a JAK2/FLT3 multikinase inhibitor for the treatment of myelofibrosis patients with severe thrombocytopenia.
- Vonjo is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109 /L (1). This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
- Vonjo capsules are administered orally twice daily with or without food.
- Common adverse reactions include diarrhea, thrombocytopenia, nausea, anemia, and peripheral edema.
Development timeline for Vonjo
|Feb 28, 2022||Approval FDA Approves Vonjo (pacritinib) for the Treatment of Adult Patients with Myelofibrosis and Thrombocytopenia|
|Jun 1, 2021||CTI BioPharma Announces Acceptance of NDA Granted with Priority Review of Pacritinib for Treatment of Patients with Myelofibrosis|
|Mar 31, 2021||CTI BioPharma Announces Completion of Rolling Submission of New Drug Application (NDA) for Pacritinib in Myelofibrosis Patients with Severe Thrombocytopenia|
|Oct 13, 2020||CTI BioPharma Initiates Rolling Submission of New Drug Application (NDA) for Pacritinib in Myelofibrosis Patients with Severe Thrombocytopenia|
|Sep 29, 2020||CTI BioPharma to Submit a New Drug Application (NDA) for the Accelerated Approval of Pacritinib for the Treatment of Myelofibrosis Patients with Severe Thrombocytopenia|
|Feb 3, 2020||CTI BioPharma Establishes Accelerated Approval Pathway for Pacritinib in Treating Myelofibrosis Patients With Severe Thrombocytopenia|
|Jul 2, 2018||CTI BioPharma Announces the Continuation without Modification of PAC203 Phase 2 Study of Pacritinib in Patients with Myelofibrosis Previously Treated with Ruxolitinib|
|Feb 9, 2016||CTI BioPharma Provides Update on Clinical Hold of Investigational Agent Pacritinib and NDA|
|Jan 5, 2016||CTI BioPharma and Baxalta Complete Submission of NDA for Pacritinib for Unmet Medical Need in Myelofibrosis|
|Nov 23, 2015||CTI BioPharma Initiates Rolling Submission of NDA for Pacritinib for the Treatment of Patients with Myelofibrosis|
|Sep 23, 2015||CTI BioPharma To Submit NDA For Pacritinib In Q4 Based Primarily On Data From Single Pivotal Persist-1 Trial|
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