Hanmi’s partner gets FDA nod for testing oral breast cancer treatment

Lee Han-soo  Published 2018.10.30  16:00  Updated 2018.10.30 16:09


Hanmi Pharmaceutical said Tuesday that Athenex, its U.S. partner, has received approval from the U.S. Food and Drug Administration for the company’s oral version of Eribulin, metastatic breast cancer and liposarcoma treatment.

Eribulin is an anticancer drug developed by the Eisai for intravenous use. Its sales surged to $360 million worldwide last year.

Athenex has developed the raw materials for Eribulin ORA through new synthetic techniques and has demonstrated excellent drug absorption in preclinical studies.

"The development will expand the applicability of Hanmi’s Orascovery platform and help the company become a major player in the development of anticancer drugs,” the company said.

Athenex’s Chief Medical Officer Rudolf Kwan, also said, “Eribulin is approved for the treatment of metastatic breast cancer patients who have received at least two prior chemotherapy regimens for late-stage disease, including both anthracycline- and taxane-based chemotherapies. It is important to note that Eribulin is active in paclitaxel-resistant tumors.”

Such profile is expected to create many synergistic opportunities with the other drug candidates in the Orascovery clinical pipeline, he added.

Hanmi, the original developers of the Orascovery platform, licensed the technology exclusively to Athenex for all major global markets except for Korea in 2011.

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