Posted by Michael Wonder on 20 Feb 2019
Agios announces FDA acceptance of supplemental new drug application for Tibsovo (ivosidenib) for the treatment of patients with newly diagnosed acute myeloid leukaemia with an IDH1 mutation not eligible for standard therapy
20 February 2019 - PDUFA date set for June 21 2019.
Agios Pharmaceuticals, today announced that the U.S. FDA has accepted the company’s supplemental new drug application for Tibsovo (ivosidenib) for the treatment of patients with newly diagnosed acute myeloid leukaemia with an isocitrate dehydrogenase 1 mutation who are not eligible for standard therapy.
The sNDA was granted priority review and has been given a Prescription Drug User Fee Act action date of 21 June 2019. In addition, the FDA accepted the Tibsovo sNDA under its 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.
