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Blood Disease Drug Dacogen Gets Thumbs Down for Cancer Use

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The vote by a panel of FDA advisers is a setback for Astex, Eisai, Johnson & Johnson. But there is still a great unmet need for new leukemia treatment, docs agree.

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A blood-disease drug known as Dacgoen did not demonstrate that it should be approved to treat a type of cancer in the elderly.

That's the word from a panel of US Food and Drug Administration advisers who voted, 10 to 3 (and one abstention), on the question whether Dacogen demonstrated a favorable risk-benefit for the treatment of patients with acute myelogenous leukemia, or AML, and who are at least 65 years old and not candidates for chemotherapy.

The vote will be considered by the FDA as it decides whether to approve the drug for a new indication. The vote is non-binding but the agency often follows the advice of its expert advisers.

The negative vote, which was expected, is a setback for the drug's developer Astex Pharmaceuticals (ASTX) and its partners Eisai of Japan and Johnson & Johnson (JNJ). Eisai sells the drug in North America, while J&J markets the product overseas. Astex receives royalties from sales.

Today's vote also is being watched by Celgene (CELG) and small-cap biotech Cyclacel Pharmaceuticals (CYCC), two companies developing their own treatments for AML, a cancer that starts in bone marrow. The cancer cells grow rapidly and replace a person's healthy blood cells. The disease usually strikes people over age 60.

AML is a tricky disease to treat. Pfizer (PFE) pulled an approved drug off the market in 2010 over questions about safety and effectiveness. That same year, Seattle Genetics (SGEN) said it scrapped development of its own drug after the treatment failed in a human trial. In 2009, Sanofi's (SNY) Genzyme failed to win FDA approval of a therapy.

Dacogen is approved to treat myelodysplastic syndrome, a disease that can lead to AML. A study of Dacogen for treating AML failed to show that the drug helped people live longer than those who received low doses of chemotherapy.

So it was interesting that the FDA convened an advisory panel to discuss the drug rather than just reject the application for a new use. But it appears that the agency folks are struggling with simply rejecting a drug that potentially treats a serious unmet need. Indeed, some doctors on the panel struggled on the question of Dacogen's benefits as they expressed desire for better treatment. Dacogen already is being prescribed by some doctors to treat AML even though the drug isn't approved for that use.

"The study failed to meet the primary endpoint, which according to FDA guidance means it isn't sufficient for approval," says biotech industry consultant Michael Becker, who advises Cyclacel. "However, AML represents a disease with limited treatment options, which is why the (FDA) panel is debating the merits of Dacogen."

Astex's stock was halted Thursday. It fell earlier in the week after FDA staff expressed concern about the drug's benefit for blood cancer patients. The stock is still up 16% this year, closing at $2.19 a share Wednesday.

"AML is a tough disease and patients need better options, especially with the elderly population increasing in the years and decades ahead," Becker says.

Twitter: @brettchase

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