Shots:

• The approval is based on the results from a P-III study that involves assessing Vyxeos (IV infusion) vs a current conventional treatment group in 309 adult patients aged 60-75 yrs. with newly diagnosed t-AML or AML-MRC
• The study met its 1EPs i.e the therapy demonstrates the improvement in OS; m-OS (9.6 vs 6.0 mos.)
• Vyxeos (daunorubicin & cytarabine liposome) is a 1st CT treatment option for adults with newly diagnosed t-AML or AML with AML-MRC while the therapy has developed with the company's CombiPlex platform to facilitate the design & rapid evaluation of various combinations of therapies

  Ref: Jazz Pharmaceuticals | Image: Jazz Pharmaceuticals