Hanmi Pharmaceutical's Oral Anticancer Drug 'Oracsol' Designated for FDA Priority Review

[Asia Economy Reporter Cho Hyun-ui] Hanmi Pharmaceutical's U.S. partner Athenex announced on the 2nd that the U.S. Food and Drug Administration (FDA) has designated the oral anticancer drug 'Oraxol' for priority review.

The FDA operates a priority review system for drugs that have the potential to provide significant improvements in effectiveness and safety in the treatment, diagnosis, or prevention of serious diseases. Unlike the standard review process, which typically takes 10 months, the approval decision for new drugs is made within 6 months.

A Hanmi Pharmaceutical official stated, "The FDA accepted the review of the New Drug Application (NDA) for Oraxol as a treatment for metastatic breast cancer and designated Oraxol for priority review." The FDA is expected to complete the review for Oraxol's marketing approval by February 28 of next year.

The new drug application for Oraxol was based on the results of a Phase 3 clinical trial comparing the safety and efficacy of Oraxol monotherapy with paclitaxel monotherapy in patients with metastatic breast cancer.

As a result, the objective response rate (ORR), an efficacy evaluation index, showed a statistically significant improvement with Oraxol compared to intravenous paclitaxel, and the incidence of neuropathy was also lower.

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