FDA Nixes Genasense

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FDA Panel Votes Against Leukemia Drug Wed Sep 6, 2:48 PM

WASHINGTON - A proposed leukemia drug should not receive federal

approval, government advisers recommended Wednesday.

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Genasense is proposed to be given along with two other medications to

patients with the most common adult form of the blood cancer,

according to manufacturer Genta Inc. But a Food and Drug

Administration panel of cancer drug experts recommended against

approval in a 7-3 vote.

The FDA isn't required to follow the advice of its advisory

committees, but usually does. The Berkeley Heights, N.J. company said

it expects to hear from the FDA by Oct. 29.

" We remain committed to the development of this agent and will

continue working with FDA regarding their review of this

application, " Dr. P. Warrell Jr., Genta's chief executive

officer, said in a statement.

Earlier, FDA reviewers said that more leukemia patients responded to

chemotherapy when the Genasense is added to their treatment mix, but

cautioned that the overall difference is of " questionable clinical

significance. " Adding the drug also appears to increase the toxicity

of the treatment, the FDA said.

Genta previously sought FDA approval for Genasense in treating

advanced melanoma. In 2004, an outside panel of FDA experts voted

against recommending the drug be approved for that use. The company

then withdrew that application for the drug, also known as oblimersen

sodium.

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