FDA approves first treatment for certain types of poor-prognosis AML
The US Food and Drug Administration has approved Vyxeos (daunorubicin and cytarabine) liposome for injection for the treatment of adults with two types of acute myeloid leukemia (AML), a rapidly progressing and life-threatening blood cancer.
Vyxeos, from Ireland-incorporated Jazz Pharmaceuticals (Nasdaq: JAZZ), is indicated for the treatment of adults with newly-diagnosed t-AML or myelodysplasia-related changes (AML-MRC).
News of the approval, which comes around a month earlier than expected, sent Jazz’s shares up 2.66% to $154.41 by close of trading on Thursday. Vyxeos will be commercially available within a week. RBC Capital Markets’ analysts forecasts peak sales of $235 million in 2022.
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