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AML Therapy Being Developed by LLS Partner Gets Fast Track Status

Posted by lynnesmith in The LLS Blog, 23 January 2015 · 1,731 views
CPX-351, Celator

A promising therapy being developed by Celator Pharmaceuticals – a partner of The Leukemia & Lymphoma Society – just got a boost through the review process by receiving a Fast Track Designation from the U.S. Food and Drug Administration (FDA).

LLS support is helping to advance the development of CPX-351, a special formulation of two standard chemotherapy drugs, to treat elderly patients with secondary acute myeloid leukemia(AML). This high risk form of AML has an especially grim prognosis as 80% of patients die within five years. The standard of care for patients with AML has not changed for at least 30 years.

The FDA designation makes it likely that if the therapy performs well in the later phase clinical trials, it will be made available to patients more quickly. CPX-351 is a liposomal formulation of cytarabine and daunorubicin, which delivers higher efficacy and less toxicity. In clinical trials that tested CPX-351 against standard delivery of the same two drugs, it almost doubled the number of patients who achieved complete remission, and nearly tripled the number of people surviving one year after treatment.

A Phase III trial is now underway that will compare CPX-351 with the standard of care (the ‘7+3’ combination regimen of cytarabine and daunorubicin) in patients aged 60 to 75 years. Response data should be available in the second quarter of this year and statistics on overall survival should be available in the first quarter of next year.

Under the Fast Track Designation, Celator will be able to communicate more frequently with the FDA throughout the development and review process, be able to submit sections of its application on a rolling basis, and be eligible for accelerated approval and review if the clinical data holds strong.

Celator is a partner through LLS’s Therapy Acceleration Program, which aims to speed the development of blood cancer treatments. The program is part of LLS's $79 million research portfolio, of which more than 20 percent is focused on discovering new therapies for AML.



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