Agios Announces Withdrawal of European Marketing Authorization Application for TIBSOVO® as a Treatment for Relapsed or Refractory IDH1-mutant Acute Myeloid Leukemia
Agios Pharmaceuticals, Inc. (AGIO)
Last agios pharmaceuticals, inc. earnings: 4/30 07:00 am
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Source: GlobeNewswire
– Agios Continues to Advance Two Phase 3 Combination Trials of TIBSOVO® in Newly Diagnosed AML Patients – 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
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- 4/10/24 - Form 4
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- 3/7/24 - Form 4
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