The Food and Drug Administration (FDA) has granted Orphan Drug Designation to Oraxol (Athenex) for the treatment of angiosarcoma.

Oraxol is a novel oral therapy that combines paclitaxel, a tubulin-stabilizing chemotherapeutic agent, with a non-absorbable gastrointestinal tract P-glycoprotein pump inhibitor. Currently, paclitaxel is only available in an intravenous formulation and requires patients to be premedicated to prevent infusion-related hypersensitivity reactions.

In addition to angiosarcoma, the Company is also investigating Oraxol as a treatment for metastatic breast cancer and gastric cancer.

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“This designation represents our commitment to expand the use of Oraxol, in which the active pharmaceutical ingredient is paclitaxel, to additional clinical indications based on the known efficacy of paclitaxel and the observed improved pharmacokinetic profile of Oraxol,” said Rudolf Kwan, Athenex’s Chief Medical Officer. “This is a parallel development with our clinical studies in metastatic breast cancer and gastric cancer, in which Oraxol has already shown promising efficacy and safety profile. We will be initiating the angiosarcoma clinical study soon.”

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