Tirabanibulin (Klisyri; Almirall) has been approved by the FDA to treat actinic keratosis in larger areas of the face or scalp up to 100 cm2.
Microtubule inhibitor ointment tirbanibulin has been approved as a topical medication treatment of actinic keratosis of the face or scalp for five days. It is sold in a 350 mg format. A press release states that the new approval increases the pre-treatment dose for surface area from 25 cm2 to 100 cm2.
Karl Ziegelbauer, Almirall's chief scientific officer, said in a press release that “the FDA's approval of Klisyri for actinic keratosis over a large area of the face or scalp is a significant advancement for patients and treating dermatologists.” “Dermatologists are looking for ways to treat the entire affected area to help prevent lesion progression when patients have actinic keratosis over larger areas.”
A rough, scaly area or bump on the skin caused by UV exposure is known as actinic keratosis. Actinic keratoses are often called precancerous lesions because they can develop into squamous cell carcinoma of the skin. The face, ears, bald head, neck, back of the hands and forearms, lips, and other areas of the skin that are frequently exposed to the sun are common places where they occur.
Actinic keratosis can be treated with cryotherapy, topical chemotherapy, laser surgery, or other techniques to destroy or remove the lesions. Actinic keratoses are usually curable, but they can sometimes recur. It is essential to encourage patients to have routine skin examinations even after treatment.
An additional, multicenter, open-label, phase 3 safety trial in more than 100 patients in the United States forms the basis for the authorization. The primary objectives were to evaluate the safety and tolerability of administration of tirbanibulin to adult patients with actinic keratosis of the face or balding scalp in a field measuring approximately 100 cm2. Based on the study results, the trial's results in terms of local skin responses and treatment-related adverse events (AEs) were consistent with those of the initial pivotal studies.
Investigations into the efficacy of tirbanibulin in a broader region revealed a percentage reduction in the number of actinic keratosis lesions, which was comparable to the results of the initial pivotal studies.
Dr. Neil Bhatia, principal investigator of the larger treatment area pivotal study, said in the press release that “clinicians can now treat up to 4 times the surface area, allowing increased flexibility to deliver treatment of actinic keratoses and achieve effective results with a good safety and tolerability profile for more patients.”
According to a press release, the initial approval of tirbanibulin in December 2020 was based on data from one of the largest phase 3 clinical trial programs ever conducted for a topical treatment of actinic keratosis. A total of 702 participants were enrolled in the 2 studies at 62 U.S. sites. When comparing patients treated with tirbanibulin to those treated with vehicle, the former showed a significantly higher percentage of patients with completely cleared actinic keratosis lesions (44% vs. 5% in Study 1 and 54% vs. 13% in Study 2). Additionally, the secondary objective of partial (≥75) lesion clearance was met.
The initial pivotal studies also showed a favourable safety profile; pruritus and application site discomfort occurred in 9% and 10% of patients treated with tirbanibulin, respectively, and were the most common adverse events (AEs). AEs did not result in patient withdrawal from the study.
The references:
1. FDA Approves Almirall's Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on a Large Area of the Face or Scalp Up to 100 cm2. Press Release. Almirall. June 10, 2024. Accessed June 10, 2024. https://www.almirall.com/newsroom/news/fda-approves-almirall-klisyri-tirbanibulin-for-treatment-of-actinic-keratosis-on-a-large-area-of-the-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%20squamous%20cell%20cancer%20of%20rough%20skin.
3. Almirall Announces FDA Approval of Klisyri (tirbanibulin), an Innovative New Topical Treatment for Actinic Keratosis. Press 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-novel-topical-treatment-for-actinic-keratosis
