Agios withdraws European regulatory filing for Tibsovo

19 October 2020

US cancer metabolism specialist Agios Pharmaceuticals (Nasdaq: AGIO) late Friday 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 I study do not sufficiently support a positive benefit-risk balance for the proposed indication.

Commenting on Agios’ decision, analysts SVB Leerink Research noted that this announcement was not entirely unexpected after the enasidenib (Idhifa) marketing application for IDH2-mutant r/r AML in Europe was withdrawn by Bristol Myers Squibb (NYSE: BMY) in December 2019.

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