Drug developer Genta Inc. said Friday that the Food and Drug Administration is still reviewing its proposal for a confirmatory trial for its leukemia treatment candidate.

Genasense Injection is a drug that would be used along with chemotherapy to treat chronic lymphocytic leukemia. The potentially fatal disease stems from a problem in the lymphocytes, a type of white blood cell that normally produces antibodies and serves important immune functions.

An application was submitted in December for "fast track" and "accelerated approval" programs, designed to expedite federal review for drugs that address an unmet medical need.

Genta said it revised its proposal to address issues the FDA raised in July and will work with the agency to clarify any remaining outstanding issues before the trial starts.

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