FDA Approves Fixed Chemo Combo for AML Subtypes

In just the latest case of a cancer drug sped along by the FDA, Jazz Pharmaceuticals $JAZZ today won approval for Vyxeos (CPX-351) as a new therapy for acute myeloid leukemia.

AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of white blood cells in the bloodstream.

"Vyxeos combines two commonly used chemotherapies into a single formulation that may help some patients live longer than if they were to receive the two therapies separately", Richard Pazdur, MD, of the FDA Office of Hematology and Oncology Products, said in a statement.

The FDA based the approval on data from the randomized phase 3 CLTR0310-301 trial, created to compare CPX-351 with a standard combination of cytarabine and daunorubicin (7+3) for 309 patients aged 60 to 75 years with newly diagnosed therapy-related AML or AML with myelodysplasia-related changes. The primary endpoint was overall survival. An estimated 21,380 individuals will be diagnosed this year with AML, according to the National Cancer Institute.

"Vyxeos is the first new chemotherapy advance in more than 40 years for adults with newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes", Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals, said in a company-issued press release. Those given Vyxeos lived an average of 9.6 months, compared with 5.9 months among those who took an inactive placebo.

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Frequently observed adverse events included hemorrhage, febrile neutropenia, rash, edema, nausea, mucositis, and diarrhea.

Patients who have a history of serious hypersensitivity to daunorubicin, cytarabine or any component of the formulation should not use Vyxeos. Both subtypes of AML have a poor prognosis associated with low life expectancy. Vyxeos is a fixed-combination drug containing daunorubicin and cytarabine.

The FDA previously designated Vyxeos for priority review, breakthrough therapy, and orphan drug status.

About Jazz Pharmaceuticals Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is an worldwide biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs.



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