Posted by Michael Wonder on 31 Mar 2021
Jazz Pharmaceuticals announces FDA approval of additional indication for Vyxeos (daunorubicin and cytarabine) for the treatment of secondary acute myeloid leukaemia in paediatric patients
30 March 2021 - Jazz Pharmaceuticals today announced that the U.S. FDA approved a revised label for Vyxeos (daunorubicin and cytarabine) to include a new indication to treat newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes in paediatric patients aged one year and older.
The approval of Vyxeos for this indication is supported by safety data from two single-arm trials: AAML1421, conducted by the Children's Oncology Group and CPX-MA-1201, conducted by Cincinnati Children's Hospital and evidence of effectiveness from an adequate and well-controlled study in adults.
