Approvals

This authorisation makes Vanflyta the first FLT3 inhibitor to be approved by the European Commission (EC) for the treatment of newly diagnosed FLT3-ITD positive AML, which comprises 25-30% of all new AML cases.

This approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP)andisbasedonresultsfromtheQuANTUMFirst trial. In this trial the drug, in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation, demonstrated a 22% reduction in risk of death compared to standard chemotherapy alone.

The safety profile of Vanflyta remained consistent with previous clinical trials with no new safety signals having been observed. The most common adverse events were febrile neutropenia, hypokalaemia, neutropenia and pneumonia.

Samantha Nier, network director at the Acute Leukemia Advocates Network (ALAN), commented: “This approval of Vanflyta is very welcome news for eligible patients diagnosed with FLT3-ITD positive AML each year. New medicines and treatment approaches are needed to help patients with this difficult type of leukaemia live longer, and we look forward to Vanflyta becoming available in countries throughout the EU.”

Ken Keller, global head of Oncology Business, president and CEO at Daiichi Sankyo, added: “With the approval of Vanflyta in the European Union, patients diagnosed with FLT3-ITD positive acute myeloid leukaemia may for the first time receive a targeted therapy developed and approved specifically for their disease subtype. Vanflyta is the second innovative medicine from our oncology pipeline approved in the EU and its successful development reflects our commitment to creating new standards of care for patients with cancer.”

Richard F Schlenk MD, professor and head of the Trial Center of the National Center of Tumour Diseases, Heidelberg University Hospital and German Cancer Research Center, Germany, stated: “This approval of Vanflyta represents an important advancement for frontline treatment of patients with FLT3-ITD positive acute myeloid leukaemia, an aggressive and historically difficult-to-treat subtype. Vanflyta is a potent and selective FLT3 inhibitor that significantly improved overall survival when added to standard chemotherapy and it will be a valuable treatment option for newly diagnosed FLT3-ITD positive AML.”