[{"orgOrder":0,"company":"Agios Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Agios Announces Publication of TIBSOVO\u00ae Phase 3 Data in The Lancet Oncology","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Agios Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Agios Reports Final OS Data from Phase 3 ClarIDHy Study of TIBSOVO\u00ae in Previously Treated IDH1-Mutant Cholangiocarcinoma Patients","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 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Cholangiocarcinoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Agios Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Agios Submits Supplemental New Drug Application to FDA for TIBSOVO for Patients with Previously Treated IDH1-Mutant Cholangiocarcinoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Servier","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Servier Report Positive Data from Phase 3 Study of TIBSOVO Azacitidine Combo","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"August 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Agios Pharmaceuticals","sponsor":"Sagard Healthcare Partners","pharmaFlowCategory":"D","amount":"$131.8 million","upfrontCash":"Undisclosed","newsHeadline":"Agios and Sagard Healthcare Partners Announce $131.8 Million Purchase Agreement for TIBSOVO\u00ae Royalty","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Servier","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Servier Announces FDA Filing Acceptance and Priority Review for TIBSOVO\u00ae (ivosidenib tablets) in Combination with Azacitidine for Patients with Previously Untreated IDH1-mutated Acute Myeloid Leukemia","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Servier","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Phase 3 AGILE Data of TIBSOVO\u00ae (ivosidenib tablets) in Combination with Azacitidine for Patients with Previously Untreated IDH1-mutated Acute Myeloid Leukemia Published in the New England Journal of Medicine","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Onco360","sponsor":"Servier","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"TIBSOVO\u00ae (ivosidenib) Now Available from Onco360 for the Treatment of Adult Patients with IDH1-Mutant Acute Myeloid Leukemia or Previously Treated, IDH1-Mutant Metastatic Cholangiocarcinoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Servier","sponsor":"Mission Bio","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Servier Leverages Mission Bio's Tapestri\u00ae Platform to Uncover AML Resistance Mechanisms in Pivotal TIBSOVO\u00ae (ivosidenib) Clinical Trial","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Small 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molecule","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Servier","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Servier Receives European Commission Approval of Tibsovo\u00ae (ivosidenib tablets) in IDH1-mutated Acute Myeloid Leukemia and IDH1-mutated Cholangiocarcinoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Servier","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Servier Announces FDA Filing Acceptance and Priority Review for TIBSOVO\u00ae (ivosidenib tablets) in the Treatment of IDH1-mutated Relapsed or Refractory (R\/R) Myelodysplastic Syndromes (MDS)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Servier","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Servier Announces FDA Approval of TIBSOVO\u00ae (ivosidenib tablets) for the Treatment of IDH1-Mutated Relapsed or Refractory (R\/R) Myelodysplastic Syndromes (MDS)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals for Ivosidenib
Tibsovo (ivosidenib) tablet is a small molecule inhibitor that targets the mutant isocitrate dehydrogenase 1 enzyme, which is investigated for IDH1-mutated Relapsed or refractory myelodysplastic syndromes.
TIBSOVO® (ivosidenib) tablet is a small molecule inhibitor that targets the mutant isocitrate dehydrogenase 1 enzyme, which is investigated for IDH1-mutated Relapsed or refractory myelodysplastic syndromes.
Tibsovo® (ivosidenib tablets) is the first and only IDH1 inhibitor approved in Europe. It has received orphan medicine designation recognizing the significant benefit brought to patients by Tibsovo® over available therapies for both CCA and AML.
Tibsovo (ivosidenib) is a small molecule inhibitor that targets the mutant isocitrate dehydrogenase 1 (IDH1) enzyme. In patients with AML, susceptible IDH1 mutations are defined as those leading to increased levels of 2-hydroxyglutarate (2-HG) in the leukemia cells.
TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with Newly Diagnosed Acute Myeloid Leukemia (AML) susceptible IDH1 mutation.
TIBSOVO® (ivosidenib) is an oral, targeted therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with an isocitrate dehydrogenase-1 (IDH1) mutation with acute myeloid leukemia (AML) or cholangiocarcinoma (bile duct cancer).
TIBSOVO® (ivosidenib), which is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with newly diagnosed acute myeloid leukemia (AML).
Through this collaboration, Servier has worked with Mission Bio’s Pharma Assay Development services to utilize Tapestri single-cell DNA sequencing technology to serially assess hundreds of samples with IDH1-mutated AML who have been treated with TIBSOVO (ivosidenib).
Global Phase 3 trial of TIBSOVO met its primary endpoint of event-free survival and all key secondary endpoints, complete remission rate, overall survival, complete remission and complete remission with partial hematologic recovery rate and objective response rate.
sNDA is based on data from AGILE trial demonstrate improved event-free survival and overall survival of TIBSOVO, the first therapy targeting cancer metabolism in combination with azacitidine in previously untreated IDH1-mutated acute myeloid leukemia.