Hanmi's cancer therapy Oraxol gets FDA's special designation

By Lim Chang-won Posted : April 20, 2018, 13:31 Updated : April 20, 2018, 13:31

[Courtesy of Hanmi Pharmaceutical]

SEOUL -- Oraxol, a novel oral therapy for cancer developed by South Korea's leading drug maker Hanmi Pharmaceutical, has won a special designation from the U.S. Food and Drug Administration (FDA) for the treatment of angiosarcoma.

Hanmi said Friday that Oraxol has won FDA's Orphan Drug Designation (ODD), which is granted to drugs intended for the safe and effective treatment of rare diseases and disorders that affect fewer than 200,000 people in the United States. The ODD status provides certain benefits including a tax reduction.

Oraxol's global sales were licensed to U.S. company Athenex in 2011. The U.S. company said in a message posted on its website that Oraxol is presently in a Phase 3 trial in metastatic breast cancer and poised to enter into a combination study for the treatment of advanced gastric cancer with ramucirumab through a clinical trial collaboration with Eli Lilly and Company.
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