Posted by Michael Wonder on 19 Oct 2020
Agios announces withdrawal of European marketing authorisation application for Tibsovo as a treatment for relapsed or refractory IDH1 mutant acute myeloid leukaemia
16 October 2020 - Agios continues to advance two Phase 3 combination trials of Tibsovo in newly diagnosed AML patients.
Agios Pharmaceuticals today announced the withdrawal of its European marketing authorisation application for Tibsovo (ivosidenib tablets) for the treatment of adult patients with relapsed or refractory acute myeloid leukaemia with an isocitrate dehydrogenase-1 mutation.
The decision is based on feedback from the EMA's 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.
