ChemGenex hits FDA speed bump for Omapro
Tuesday, 23 March, 2010
Targeted leukaemia therapy company, ChemGenex, has suffered a setback in its drive for approval from the US Food and Drug Administration for it's flagship drug, Omapro.
The FDA voted seven to one that a diagnostic test needs to be approved by the FDA before Omapro can get the regulator's tick of approval.
Omapro (omacetaxine mepesuccinate) is a targeted therapy for the treatment of chronic myeloid leukemia (CML) in patients who have the T315I mutation and, as a result, are not receptive to the first line treatment, Glivec (also known as Gleevec, or imatinib).
The test required by the FDA is to diagnose the T315I mutation. There already exist a number of tests that identify the mutation, but none have been approved by the FDA.
The vote represents a delay to the approval of Omapro, although the Oncologic Drugs Advisory Committee (ODAC) remains positive about the drug and its efficacy and safety.
ChemGenex will meet with the FDA again on April 9 to review the diagnostic strategy.
“Over the past several months, ChemGenex has been working closely with the FDA on a diagnostic strategy to allow for approval of OMAPRO. We are committed to making OMAPRO available to patients as soon as possible,” said Dr Greg Collier, chief executive officer and managing director of ChemGenex, in a statement.
ChemGenex (ASX:CXD) took a hefty hit on the stock market today following the news, shedding 25.5c to 44c, a drop of 36.7%.
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