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, MA, USA I October 16, 2020 I 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’s
single 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 AML
Agios 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 chemotherapy
  • HOVON150/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 have comorbidities that preclude use of intensive induction chemotherapy.
  • Adult patients with relapsed or refractory AML.

Please see full Prescribing Information, including Boxed WARNING.

About Agios
Agios is focused on discovering and developing novel investigational medicines to treat malignant hematology, solid tumors and rare genetic diseases through scientific leadership in the field of cellular metabolism. In addition to an active research and discovery pipeline across these three therapeutic areas, Agios has two approved oncology precision medicines and multiple first-in-class investigational therapies in clinical and/or preclinical development. For more information, please visit the company's website at www.agios.com.

SOURCE: Agios

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