A New Topical Ointment for Pre-Cancer Lesions Has Been Approved by the FDA

Last week, a new topical ointment for skin pre-cancer lesions called actinic keratoses (AK’s)—the red, rough and scaly lesions most-commonly located on sun-exposed areas such as the face, scalp, ears, and hands—was approved by the FDA.

The ointment, known as Klisyri (1% tirbanibulin), comes in a single-dose packet and is applied once a day for five consecutive days. According to Denver dermatologist and Klisyri investigator Joel Cohen, MD, it is a breakthrough in the dermatological industry for a number of reasons. Klisyri has a new mechanism of action for topicals and functions as a cell microtubule inhibitor, meaning it blocks cell cycle progression extremely fast and without signs of irritation.

In With the New
“Many of the topical products we currently prescribe for AK’s were FDA-approved with several weeks of application, and they tend to cause a lot of irritation of sun-damaged skin during this timeframe,” says Dr. Cohen. Klisyri, on the other hand, was approved with a treatment duration of only five days and seems to have less of a tendency to cause skin irritation.

Dr. Cohen indicates that dermatologists use liquid nitrogen to treat thicker focal pre-cancer lesions, and also frequently incorporate prescription topical medications (including 5-fluorouracil or imiquimod) for patients to use at home. “Some patients or their physicians prefer in-office photodynamic therapy (PDT),” says Dr. Cohen.

Study Room
“The most common adverse effects in the Klisyri study, which enrolled a total of 702 patients, were application area itching (in 9 percent of patients), and application site discomfort (in 10 percent),” says Dr. Cohen. “These percentages are very small compared to other topicals.” Describing the effectiveness of the data, Dr. Cohen notes this study was one of the largest phase-three clinical study programs ever conducted for actinic keratoses.

According to Dr. Cohen, there were two parallel studies performed on adults that had actinic keratoses on their face and scalp. The primary endpoint for the study was “complete clearance”—the long-term, sustained clearance of the condition—of baseline AK lesions at day 57. In one study, the complete clearance was 44 percent versus 5 percent in the vehicle group (otherwise known as the placebo). In the other parallel study, 54 percent of patients had complete clearance versus 13 percent in the vehicle group.

“Klisyri is exciting news from the perspective of having a new topical product on the market for actinic keratoses based on a very comprehensive, large-scale clinical trial where essentially half of the patients saw a complete response with only a five day application period and a very low local skin reaction profile,” says Dr. Cohen.