Leukemia

U.S. Food and Drug Administration grants fast track designation for Troxatyl

Published in Medical Letter on the CDC and FDA, November 20th, 2005

SGX Pharmaceuticals, Inc. (SGX) announced that Troxatyl, an investigational drug in a pivotal phase II/III clinical trial, has been granted fast track designation by the U.S. Food and Drug Administration (FDA) for third-line treatment of acute myeloid leukemia (AML) in adults.

This designation may allow for the FDA to sanction company actions to expedite the development and review of a potential new drug application for Troxatyl to treat third-line AML. Fast track designation also provides the potential to seek accelerated approval in which the FDA may grant market approval based on a determination that the drug effect on a surrogate endpoint is reasonably likely to...

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Source: Medical Letter on the CDC and FDA (2005-11-20)

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