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news.The US Food and Drug Administration (FDA) has granted fast track designation for Celator Pharmaceuticals' CPX-351 (cytarabine:daunorubicin) to treat elderly patients with secondary acute myeloid leukemia (AML).
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Currently, the company has completed patient enrollment in a Phase III trial and it expects induction response rate data to be available in the second quarter of 2015.
According to the company, overall survival data, which is the primary endpoint of the trial, is expected to be reported in the first quarter of 2016.
The fast track designation provides an opportunity to the company to submit sections of a new drug application (NDA) on a rolling basis, where FDA may review portions of the NDA as they are received instead of waiting for the entire NDA submission.
Celator Pharmaceuticals chief executive officer Scott Jackson said: "We are pleased that FDA has granted fast track status for CPX-351 for the treatment of elderly patients with secondary AML.
"If our Phase III 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."
The company’s product pipeline includes CPX-351 for the treatment of acute myeloid leukemia; CPX-1 for colorectal cancer; a preclinical stage product candidate, CPX-8, being studied by the National Cancer Institute’s Nanotechnology Characterization Laboratory; and several programs exploring novel combinations of existing drugs, including molecularly targeted therapies.