[{"orgOrder":0,"company":"TG Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Umbralisib Developer Seeks FDA Approval In Marginal Zone Lymphoma and Follicular Lymphoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"TG Therapeutics","sponsor":"Not Applicable ","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"TG Therapeutics Receives Orphan Drug Designation for Umbralisib ","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"TG Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"TG's Leukemia Combo Clears Phase 3, Aims for 2020 Filing","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"TG Therapeutics","sponsor":"J.P. 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Lymphoma Medicine Ukoniq (Umbralisib) Is Withdrawn Due to Safety Concerns","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals for Umbralisib
Ukoniq (umbralisib), is the first and only oral inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon, is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma.
The BLA/sNDA submissions of U2 to treat CLL were based on results of UNITY-CLL trial, comparing the combination of TG-1101 (ublituximab) plus UKONIQ (umbralisib), or U2, to an active control arm of obinutuzumab plus chlorambucil in patients with both treatment-naïve CLL.
The results showed a possible increased risk of death in patients receiving the combination of Ukoniq and the monoclonal antibody compared to the control arm. And also experienced more serious adverse events than those in the control arm.
The UNITY-CLL Phase 3 trial continued enrollment in a 1:1 ratio into the two combination arms: the investigational arm of U2 and the control arm of obinutuzumab plus chlorambucil.
The UNITY-CLL Phase 3 trial continued enrollment in a 1:1 ratio into the two combination arms: the investigational arm of U2 and the control arm of obinutuzumab plus chlorambucil.
The Company to review the updated Phase 1 data evaluating the investigational combination of UKONIQ® (umbralisib) and ublituximab (U2) plus venetoclax presented at iwCLL, as well as provide an overview of the ULTRA-V Phase 2/3 trial.
TG Therapeutics has completed a rolling submission of a BLA to the U.S. FDA requesting approval of ublituximab, in combination with UKONIQTM (umbralisib), as a treatment for patients with CLL, based on the positive results from the UNITY-CLL Phase 3 trial.
Umbralisib (UKONIQ) granted accelerated approval by US FDA for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL), follicular lymphoma (FL).
UKONIQ is the first and only, oral, once daily, inhibitor of phosphoinositide 3 kinase delta and casein kinase 1 epsilon. UKONIQ is approved for adult patients with relapsed or refractory marginal zone lymphoma after at least one prior anti-CD20 based regimen.
TG Therapeutics has initiated a rolling submission of a Biologics License Application to the U.S. FDA requesting approval of ublituximab, a glycoengineered anti-CD20 monoclonal antibody, in combination with umbralisib, an oral, dual inhibitor of PI3K-delta and CK1-epsilon.
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