Posted by Michael Wonder on 03 May 2019
Agios announces FDA approval of supplemental new drug application for Tibsovo as monotherapy for newly diagnosed adult patients with IDH1 mutant acute myeloid leukaemia not eligible for intensive chemotherapy
2 May 2019 - Approval based on 28 newly diagnosed patients from Phase 1 study of Tibsovo in advanced haematologic malignancies with an IDH1 mutation.
Agios Pharmaceuticals today announced the U.S. FDA approved a supplemental new drug application to update the U.S. Prescribing Information for Tibsovo, an isocitrate dehydrogenase-1 (IDH1) inhibitor, to include adult patients with newly diagnosed acute myeloid leukaemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test who are ≥ 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
The application was granted priority review and accepted under the FDA's real-time oncology review pilot program, which aims to make the review of oncology drugs more efficient by allowing the FDA access to clinical trial data before the information is formally submitted to the agency.
