Celator receives FDA breakthrough therapy designation for leukaemia drug

pharmafile | May 20, 2016 | News story | Medical Communications, Research and Development FDA, Vyxeos, acute myeloid leukaemia, breakthrough therapy, celator 

A new treatment for acute myeloid leukaemia and other blood cancers from Celator Pharmaceuticals (NASDAQ: CPXX) has been granted breakthrough therapy designation from the US Food and Drug Administration (FDA).

Vyxeos performed well in late stage trials in older patients with previously untreated high-risk acute myeloid leukaemia (AML). The median overall survival for patients treated with the drug in the Phase III trial was 9.56 months, representing a 3.61 month improvement over other treatments. The percentage of patients still alive after both one and two years was also higher with Vyxeos.

The trial met its primary endpoint demonstrating a statistically significant improvement in overall survival and it was these results that formed the basis for the breakthrough therapy designation.

Scott Jack, chief executive officer at Celator, says: “The breadth of the designation, which includes all adults with t-AML and AML-MRC, is encouraging as AML patients are in need of advancements in treatment. We look forward to working with the FDA to bring Vyxeos to patients as quickly as possible.”

Celator plans to submit a new drug application to the FDA by the end of Q3 of this year. Their stock has risen 10.35% at the time of writing.

Sean Murray

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