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Jazz Pharma's acute myeloid leukaemia drug scores EU approval

Published on 29/08/18 at 11:14am

Jazz Pharmaceuticals has revealed that its advanced liposomal formulation Vyxeos has received approval from the European Commission for the treatment of newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adult patients.

The decision, which makes the product available to patients across Europe, was based on data from five studies, one of which was a Phase 3 study investigating the efficacy of Vyxeos compared to 7+3 chemotherapy in 309 65-70-year-old participants with newly diagnosed t-AML or AML-MRC.

In the study, Vyxeos met its primary endpoint, recording a median overall survival of 9.6 months compared to 5.9 months with chemotherapy. The drug also demonstrated a complete response rate of 37% compared to 26% with chemotherapy, and a rate of haematopoietic stem cell transplant (HSCT) of 34% compared to 25%.

“Vyxeos is the first chemotherapy to demonstrate an overall survival advantage versus the standard of care in a Phase 3 study of older adult patients with newly diagnosed therapy- related AML or AML with myelodysplasia-related changes,” said Daniel Swisher, President and CEO at Jazz Pharmaceuticals. “Jazz is committed to making Vyxeos available to patients in the EU and we will now pursue rolling launches of Vyxeos across the European Union on a country-by-country basis as pricing and reimbursement decisions are made.”

Professor Charles Craddock, Academic Director, Centre for Clinical Haematology at University Hospitals Birmingham NHS Foundation Trust.

“AML is a rare cancer in Europe and patients with therapy-related AML or AML with myelodysplasia-related changes have a particularly poor prognosis compared to people with other forms of leukaemia. Vyxeos is a new and clinically meaningful treatment option that provides a welcome advance for patients and health care professionals across the European Union.”

Matt Fellows

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