FDA Approves Tirbanibulin for Actinic Keratosis on Expanded Area of Face or Scalp


The new approval increases the previous dosing for surface area treatment from 25 cm2 to up to 100 cm2.

The FDA has approved tirbanibulin (Klisyri; Almirall) for use on larger areas of the face or scalp up to 100 cm2 to address actinic keratosis.1

Tirbanibulin is a microtubule inhibitor ointment and is now approved in a 350 mg package size as a 5-day topical field treatment for actinic keratosis of the face or scalp. The new approval increases the previous dosing for surface area treatment from 25 cm2 to up to 100 cm2, according to a news release.1

Man pointing to a melanoma spot on his cheek, skin cancer, actinic keratosis

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“The FDA’s approval of the use of Klisyri for actinic keratosis on an extended surface of the face or scalp is a significant step forward for both patients and treating dermatologists,” said Karl Ziegelbauer, chief scientific officer at Almirall, in a news release. “With patients experiencing [actinic keratosis] over larger surface areas, dermatologists are looking for ways to treat the entire affected area to help prevent further lesion progression.”1

Actinic keratosis is characterized as a rough, scaly patch or bump on the skin caused by ultraviolet damage. Importantly, some actinic keratoses can turn into squamous cell skin cancer, so the lesions are often called precancerous. It most commonly appears on areas of the skin most often exposed to the sun, including the face, ears, bald scalp, neck, backs of hands and forearms, and lips.2

Treatment options for actinic keratosis can include cryotherapy, topical chemotherapy, laser surgery, or other treatments to remove or destroy the lesion. Most actinic keratoses can be treated or cured, although in rare cases they can return. It is important to encourage patients to have regular skin exams even after treatment.2

The approval is based on an additional phase 3, multicenter, open-label, clinical safety study with more than 100 participants in the US. The primary end points were to evaluate the safety and tolerability of applying tirbanibulin to a field of approximately 100 cm2 on the face or balding scalp of adult patients with actinic keratosis. According to the study findings, the trial found consistent results with the original pivotal trials, for both local skin reactions and treatment-related adverse events (AEs).1

The efficacy of tirbanibulin in a larger area was also researched and showed a percent reduction in actinic keratosis lesion count similar to the one reported in the original pivotal studies.1

“With this new FDA approval, clinicians can now treat up to 4 times the surface area, allowing increased flexibility to provide treatment of actinic keratoses and achieve effective results with a good safety and tolerability profile for more patients,” said Neil Bhatia, MD, principal investigator for the larger treatment area pivotal study, in the news release.1

The initial approval of tirbanibulin, in December 2020, was based on findings from one of the largest phase 3 clinical study programs ever conducted for a topical actinic keratosis treatment, according to a news release. The 2 studies enrolled a total of 702 patients across 62 sites in the US. Tirbanibulin demonstrated a significantly higher number of patients with 100% clearance of actinic keratosis lesions in the treated area compared with the vehicle (44% vs 5% in study 1, and 54% vs 13% in study 2). It also achieved the secondary end point of partial (75) clearance of lesions.3

The original pivotal trials also demonstrated a positive safety profile, with the most common AEs being application site pruritis and pain in 9% and 10%, respectively, of patients treated with tirbanibulin. No patients withdrew from the study due to AEs.3


1. FDA approves Almirall’s Klisyri (tirbanibulin) for the treatment of actinic keratosis on expanded area of face or scalp up to 100 cm2. News release. Almirall. June 10, 2024. Accessed June 10, 2024. https://www.almirall.com/newsroom/news/fda-approves-almirall-s-klisyri-tirbanibulin-for-the-treatment-of-actinic-keratosis-on-expanded-area-of-face-or-scalp-up-to-100-cm2

2. Actinic Keratosis (A Precancerous Condition). Johns Hopkins Medicine. Accessed June 10, 2024. https://www.hopkinsmedicine.org/health/conditions-and-diseases/actinic-keratosis#:~:text=Actinic%20keratosis%20is%20a%20rough,into%20squamous%20cell%20skin%20cancer.

3. Almirall announces FDA approval of Klisyri (tirbanibulin), a new innovative topical treatment for actinic keratosis. News release. Almirall. December 15, 2020. Accessed June 10, 2024. https://www.almirall.com/newsroom/news/almirall-announces-fda-approval-of-klisyri%C2%AE-tirbanibulin-a-new-innovative-topical-treatment-for-actinic-keratosis

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