SILVER SPRING, Md., Oct. 24, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Tibsovo (ivosidenib) for the treatment of adult patients with relapsed or refractory (R/R) myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. This is the first targeted therapy approved for this indication. The agency also approved the Abbott RealTime IDH1 Assay as a companion diagnostic for the selection of R/R MDS patients with an IDH1 mutation.
BOSTON, Oct. 24, 2023 /PRNewswire/ -- Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, today announced the U.S. Food and Drug Administration (FDA) has approved TIBSOVO® (ivosidenib tablets) for the treatment of patients with isocitrate dehydrogenase 1 (IDH1)-mutated relapsed or refractory (R/R) myelodysplastic syndromes (MDS). This is the fifth indication for TIBSOVO across IDH1-mutated cancers, and the first and only approved targeted therapy for people diagnosed with R/R MDS within this molecularly defined subset.
BOSTON, Aug. 15, 2023 /PRNewswire/ -- Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, today announced the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for TIBSOVO® (ivosidenib tablets) in the treatment of patients with isocitrate dehydrogenase 1 (IDH1)-mutated relapsed or refractory (R/R) myelodysplastic syndromes (MDS). If approved, TIBSOVO would be a first-in-class targeted therapy option for MDS patients within this molecularly defined subset.
BOSTON, June 9, 2023 /PRNewswire/ -- Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, today announced updated data from the Phase 1 trial of TIBSOVO® (ivosidenib tablets) as monotherapy for patients with isocitrate dehydrogenase 1 (IDH1)-mutated relapsed or refractory (R/R) myelodysplastic syndromes (MDS). The results presented today at the European Hematology Association (EHA) 2023 Annual Congress in Frankfurt, Germany demonstrate that the efficacy and safety profile of TIBSOVO may provide an important new treatment option for MDS patients within this molecularly defined subset.
Les Laboratoires` Tibsovo (ivosidenib) Receives Approval in the Europe
Servier has received marketing authorisation from the European Commission (EC) for Tibsovo (ivosidenib tablets) to treat isocitrate dehydrogenase-1 (IDH1)-mutated acute myeloid leukaemia (AML) and IDH1-mutated cholangiocarcinoma.
PARIS, Feb. 24, 2023 /PRNewswire/ -- Servier, a global pharmaceutical company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorization for Tibsovo® (ivosidenib tablets) - an inhibitor of the mutated isocitrate dehydrogenase-1 (IDH1) enzyme - for two indications:
BOSTON, Dec. 10, 2022 /PRNewswire/ -- Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, today presented new data at the 64th Annual Meeting of the American Society of Hematology (ASH) characterizing clonal evolution and relapse mechanisms in patients with newly-diagnosed IDH1-mutated acute myeloid leukemia (AML) who are 75 years of age or older or have comorbidities that preclude use of intensive induction chemotherapy treated with TIBSOVO in combination with azacitidine.
The approval gives Rigel, a biotech that’s been around since the mid-1990s, its second marketed medicine and a competitor to Servier’s Tibsovo.
Almost two years after Agios sold its oncology unit to French pharma Servier in a $1.8 billion deal, Agios is letting go of its last link to one of its old medicines.