Genzyme Announces Results Of Phase 3 Trial Of Clolar In Adult AML

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Genzyme Announces Results Of Phase 3 Trial Of Clolar In Adult AML

Genzyme Corporation (Nasdaq: GENZ) announced results today from its CLASSIC I phase 3 trial comparing Clolar® (clofarabine) in combination with the chemotherapy agent cytarabine (ara-c) to cyt

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Tags: Cancer, Chemotherapy, Leukemia, Acute Myelogenous Leukemia, Phase 3 Clinical Trial, Genzyme

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Genzyme Announces Results of Phase 3 Trial of Clolar in Adult AML | Business Wire

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FDA: Randomized clinical trial necessary to better interpret Clolar's efficacy and safety in adult AML

news-medical.net — “Genzyme Corporation (Nasdaq: GENZ) announced today that the FDA's Oncologic Drugs Advisory Committee voted 9 to 3 that a randomized, controlled trial is needed to support the currently proposed label expansion for Clolar® (clofarabine) in adult myeloid leukemia (AML). The committee found that the single-arm clinical study results submitted to support the label expansion showed Clolar was an active agent in acute AML patients, but concluded that a randomized clinical trial should be necessar” View full resource at news-medical.net