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FDA Approves New AK Treatment

Tirbanibulin 1% ointment has been approved by the FDA for the treatment of actinic keratosis (AK) on the face and scalp. This topical therapy is a first-in-class microtubule inhibitor for the treatment of AKs.1

Approval was based on data from two pivotal randomized, double-blind, vehicle-controlled phase 3 studies (KX01-AK-003 and KX01-AK-004). In the trials, 702 adult patients with AKs on the face or scalp were randomized to vehicle or tirbanibulin 1% ointment once daily for 5 consecutive days. At day 57, more patients treated with tirbanibulin achieved complete clearance of AK lesions (44% in KX01-AK-003 study and 54% in the KX01-AK-004) compared with vehicle (5% and 13%).2,3

The most commonly reported adverse events were local skin reactions, application site pruritus, and application site pain. In addition, tirbanibulin ointment may cause eye irritation. Patients should wash their hands immediately after application to avoid this adverse reaction.

References

1. Athenex announces FDA approval of Klisyri® (tirbanibulin) for the treatment of actinic keratosis on the face or scalp. News release. Athenex. Published December 15, 2020. Accessed December 15, 2020. https://ir.athenex.com/news-releases/news-release-details/athenex-announces-fda-approval-klisyrir-tirbanibulin-treatment

2. Athenex. A multi-center study to evaluate the efficacy and safety of KX2-391 ointment 1% on AK on face or scalp (AK003). NCT03285477. Accessed December 15, 2020. https://clinicaltrials.gov/ct2/show/NCT03285477

3. Athenex. A multi-center study to evaluate the efficacy and safety of KX2-391 ointment 1% on AK on face or scalp (AK004). NCT03285490. December 15, 2020. https://clinicaltrials.gov/ct2/show/NCT03285490

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