EMA suspends Picato as a precaution while review of skin cancer risk continues

In September 2019, at the request of the European Commission, the European Medicines Agency's safety committee (the Pharmacovigilance Risk Assessment Committee - PRAC) commenced a review of data on skin cancer in patients using Picato (ingenol mebutate), a gel indicated for the treatment of cutaneous treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis in adults. The product information includes a warning in relation to keratoacanthoma and was updated to also include basal cell carcinoma, Bowen's disease and squamous cell carcinoma.

The HPRA writes to inform you that further to PRAC's review of the data, the PRAC has recommended suspending the medicine's marketing authorisation as an interim measure to protect public health while the review is ongoing, due to concerns about a possible increased risk of skin cancer. Final results from a study comparing Picato with imiquimod (another medicine for actinic keratosis) indicate a higher occurrence of skin cancer in the treatment area with Picato than with imiquimod.

While uncertainties remain, there is concern about a possible link between the use of Picato and the development of skin cancer. The PRAC also noted that alternative treatments are available. The PRAC's recommendation to suspend the marketing authorisation as an interim measure will now be forwarded to the European Commission, which will issue a provisional legally binding decision applicable in all EU Members States.

As a precaution, patients should no longer use Picato gel to treat actinic keratosis, while authorities review the data. Patients should look out for any unusual skin changes or growths and seek medical advice promptly if any occur. If patients have any questions, they should speak with their doctor.

Healthcare professionals should stop prescribing Picato and consider different treatment options, while authorities review the data, and should advise patients to be vigilant for any skin lesions developing and to seek medical advice promptly should any occur.

A direct healthcare professional communication (DHPC) is to follow.

The PRAC will continue its review and once this review is concluded, the final recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt an opinion. When the review has concluded, EMA will provide updated guidance to patients and healthcare professionals.

Please find attached the EMA's communication published on their website today with a link below to this announcement.