FDA panel generally positive about omacetaxine

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The FDA's Oncologic Drugs Advisory Committee today voted 7-1 to recommend to the agency that they ought to review a diagnostic test to identify patients with the T3151 genetic mutation prior to giving approval to ChemGenex Pharmaceuticals' Omapro (omacetaxine) as a treatment for patients with chronic myeloid leukemia (CML) who did not respond to initial treatment with Gleevec (imatinib).

Despite the recommendation, the panel was generally positive about Omapro as a safe and effective treatment option.

By Ross Bonander

Source: bioworld.com

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