AML Archives - Regulatory Professionals

November 30, 2018

New combination therapy for AML approved by FDA

A combination of a standard drug and the novel agent venetoclax – has been granted accelerated approval by the FDA for patients after a large, multicenter phase 1 clinical trial showed the combination had “promising efficacy” and was well tolerated in older AML patients. “I think it’s likely to become a standard for patients in

Written by Kathleen McCarthy

October 13, 2017

Astellas AML treatment receives fast track designation from FDA

Astellas Pharma has received fast-track designation in the US for its FLT3 inhibitor, Gilteritinib, a drug that could potentially rival Novartis’ budding $250m-plus product Rydapt (Midostaurin). The FDA gave the status to Gilteritinib as a treatment for adults with FLT3-mutation-positive relapsed or refractory acute myeloid leukaemia (AML), a cancer that impacts blood and bone marrow.

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New combination therapy for AML approved by FDA

Astellas AML treatment receives fast track designation from FDA

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