Genta Incorporated received orphan drug designation from the U.S. Food and Drug Administration for their investigative agent tesetaxel in the treatment of advanced melanoma.
Tesetaxel is an oral semi-synthetic taxane that was developed to reduce hypersensitivity reactions associated with intravenous infusion administration of other taxanes and improve convenience of dosing for patients. Tesetaxel is currently in late Phase II studies and has demonstrated a reduction in the nerve damage often associated with the taxane prototypes paclitaxel and docetaxel and no severe infusion reactions.
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