The safety committee of the European Medicines Agency (EMA) has recommended that the licence for Picato (ingenol mebutate) be suspended while it continues a safety review of the drugs potential link to skin cancer.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) initiated the review after data emerged suggesting a higher occurrence of skin malignancy in the treatment area with Picato than with imiquimod. The three-year study (n=484) found that the incidence of skin cancer was 3.3 per cent with ingenol mebutate versus 0.4 per cent with imiquimod.
A similar association was observed in an eight-week trial of 1,262 patients, showing an incidence of 1 per cent in the ingenol mebutate arm versus 0.1 per cent with imiquimod.
Furthermore, four clinical trials (n=1,234) have found that ingenol disoxate is associated with higher incidence of skin tumours compared to a vehicle control (7.7% vs 2.9%, respectively). As ingenol disoxate is closely related to Picato, the results are considered relevant in the ongoing review of Picato.
The EMA is advising healthcare professionals not to prescribe Picato and to consider different treatment options while authorities review the data. Patients should be advised to be vigilant for skin lesions and seek medical advice promptly.