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FDA grants fast track designation to CPX-351 for AML
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The FDA granted fast track designation to the experimental agent CPX-351 for treatment of elderly patients with secondary acute myeloid leukemia, the drug’s manufacturer announced.
CPX-351 (Celator Pharmaceuticals) is a liposomal formulation of the chemotherapeutic agents cytarabine and daunorubicin that is intended to deliver synergistic drug ratios to leukemia cells.
The FDA’s fast track program is intended to facilitate the development and expedite the review of new drugs intended to treat serious conditions, as well as agents that would fill unmet medical needs.
A randomized phase 2 study published last year compared CPX-351 with conventional administration of cytarabine and daunorubicin as first-line treatment in 126 older patients with newly diagnosed AML.
Patients aged 60 to 75 years were eligible. Response rate served as the primary endpoint, and EFS and OS served as secondary endpoints.
Patients assigned CPX-351 demonstrated a higher response rate (66.7% vs. 51.2%; P=.07). Researchers observed no significant differences in EFS or OS.
A planned analysis of patients with secondary AML showed patients assigned CPX-351 induced a higher response rate (57.6% vs. 31.6%; P=.06), longer EFS (HR=0.59; P=.08) and longer OS (HR=0.46; P=.01).
Patients treated with CPX-351 demonstrated slower recovery from cytopenia. Median time to absolute neutrophil count ≥1,000 (36 days vs. 32 days), as well as median time to platelet count >100,000 (37 days vs. 28 days), were longer in the CPX-351 arm. Patients treated with CPX-351 also developed more grade 3 or grade 4 infections. However, researchers observed no increase in infection-related deaths (3.5% vs. 7.3%) or rate of 60-day mortality (4.7% vs. 14.6%) in the CPX-351 group.
A phase 3 trial designed to evaluate CPX-351 in patients with newly diagnosed secondary AML is underway, and enrollment is complete.
“We expect induction response rate data to be available in the second quarter of this year, and to have overall survival data — the primary endpoint of the study — in the first quarter of 2016,” Scott Jackson, CEO of Celator Pharmaceuticals, said in a press release. “If our phase 3 study comparing CPX-351 to the current standard of care is successful, the fast track designation may provide an added benefit of facilitating the NDA review process.”