FDA sends a message

By not even asking for a vote on ChemGenex Pharmaceuticals Ltd.'s Omapro omacetaxine mepesuccinate at last week's Oncologic Drugs Advisory Committee meeting, FDA sent a clear message to companies developing personalized medicines: validation of a diagnostic assay to identify patients likely to benefit is a pre-approval requirement.

ChemGenex plans to validate an in vitro sequencing method using samples from its pivotal study, which it hopes will be enough to get Omapro approved to treat T315I-positive chronic myeloid leukemia (CML)...