UPDATE : Monday, September 7, 2020
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FDA grants priority review to Hanmi’s Oraxol
  • By Lee Han-soo
  • Published 2020.09.02 13:06
  • Updated 2020.09.02 13:06
  • comments 0

Hanmi said the U.S. Food and Drug Administration has approved the new drug application (NDA) for Oraxol as requested by its U.S. partner, Athenex, and designated it as a subject for priority review.

Hanmi’s Oraxol will receive the FDA’s priority review. (Hanmi)

Oraxol is an oral anticancer treatment for metastatic breast cancer,

The FDA grants priority review to applications for potential drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. Unlike a general review, which usually takes 10 months, the FDA decides within six months under the priority review.

According to the Prescription Drug User Fee Act, the FDA plans to complete the review of Oraxol’s marketing authorization by Feb. 28 next year.

“We are actively discussing priorities with the FDA so that we can provide solutions to metastatic breast cancer patients as soon as possible,” Athenex CMO Rudolf Kwan said. “We will continue to invest in expanding the label and use of Oraxol.”

Athenex CEO Johnson Lau also said, “Preparations for the successful launch of Oraxol are in progress.”

Amid the ongoing pandemic situations, the company is paying attention to the potential value of Oraxol, which can enable cancer patients to receive chemotherapy at their homes, Lau added.


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