The FDA has accepted a new drug application (NDA) from Jazz Pharmaceuticals, granting priority review to the company’s novel CPX-351 injection (Vyxeos) for acute myeloid leukemia (AML).
The FDA granted CPX-351 fast track status for the treatment of elderly patients with secondary AML in January 2015. That decision was based on results from a pair of phase II studies in which CPX-351 showed promising results for patients with newly diagnosed and relapsed AML.
Lancet JE, Uy GL, Cortes JE, et al. Final results of a phase III randomized trial of CPX-351 versus 7+3 in older patients with newly diagnosed high risk (secondary) AML. J Clin Oncol. 34, 2016 (suppl; abstr 7000).
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