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Agios Announces Withdrawal of European Marketing Authorization Application for TIBSOVO® as a Treatment for Relapsed or Refractory IDH1-mutant Acute Myeloid Leukemia
– Agios Continues to Advance Two Phase 3 Combination Trials of TIBSOVO® in Newly Diagnosed AML Patients – CAMBRIDGE, Mass., Oct. 16, 2020 (GLOBE NEWSWIRE) --
About this update from Agios Pharmaceuticals, Inc.
[{"type":"text","content":"– Agios Continues to Advance Two Phase 3 Combination Trials of TIBSOVO® in Newly Diagnosed AML Patients –\n CAMBRIDGE, Mass., Oct. 16, 2020 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced the withdrawal of its European Marketing Authorization Application (MAA) for TIBSOVO® (ivosidenib tablets) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) mutation. The decision is based on feedback from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) that the available clinical data from the company’ssingle arm, uncontrolled Phase 1 study do not sufficiently support a positive benefit-risk balance for the proposed indication. “We are disappointed not to be able to bring TIBSOVO® to AML patients in the EU based on our current data in the relapsed/refractory setting, given the tremendous need for new targeted treatment options for this devastating disease,” said Chris Bowden, M.D., chief medical officer at Agios. “We continue to believe in the benefit of TIBSOVO® for patients with AML and are advancing our two ongoing Phase 3 randomized controlled trials evaluating TIBSOVO® combinations in newly diagnosed AML. If these trials are positive, we anticipate pursuing approvals in these indications in both the U.S. and EU.” About TIBSOVO® Clinical Development in AMLAgios is currently enrolling two Phase 3 combination trials in newly diagnosed AML: AGILE, a Phase 3 trial of TIBSOVO® in combination with azacitidine in newly diagnosed AML patients who are not eligible for intensive chemotherapyHOVON150/AMLSG29, an intergroup-sponsored Phase 3 trial evaluating TIBSOVO® or IDHIFA® (enasidenib) in combination with standard induction and consolidation chemotherapy in newly diagnosed AML patients who are eligible for intensive chemotherapy The majority of AML patients with an IDH1 mutation are eligible for intensive therapy or non-intensive therapy. About TIBSOVO® (ivosidenib)TIBSOVO® is indicated for the treatment of acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in: Adult patients with newly-diagnosed AML who are ≥75 years old or who ...