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

Κατηγορίες: Featured, Επιστημονική Ενημέρωση

On 16 January 2020, EMA recommended that patients stop using Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, while it continues its review of the medicine’s safety.

EMA’s safety committee (PRAC) is currently reviewing data on skin cancer in patients using Picato. 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 therefore recommended suspending the medicine’s marketing authorisation as a precaution and noted that alternative treatments are available.

The PRAC will continue its review and when the review has concluded, EMA will provide updated guidance to patients and healthcare professionals.

The final results of a three-year study in 484 patients showed a higher incidence of skin malignancy with ingenol mebutate than with the comparator imiquimod (3.3% of patients developed cancer in the Picato group versus 0.4% in the comparator group).

A higher incidence of skin tumours occurred in the ingenol mebutate arm of an 8-week vehicle-controlled trial in 1,262 patients (1% of patients in the ingenol mebutate arm versus 0.1% in the vehicle arm).

In addition, in four clinical trials involving 1,234 patients with a related ester, ingenol disoxate, a higher incidence of skin tumours occurred with ingenol disoxate than with a vehicle control (7.7% versus 2.9% of patients, respectively). As ingenol disoxate is closely related to Picato, the results were considered relevant in the ongoing review of Picato.

Healthcare professionals should stop prescribing Picato and consider different treatment options, while authorities review the data.

Healthcare professionals should advise patients to be vigilant for any skin lesions developing and to seek medical advice promptly should any occur.

EMA continues its review of the available data and will provide further information when the review concludes.

A direct healthcare professional communication (DHPC) will be sent to relevant healthcare professionals on or around 27 January 2020. The DHPC will also be published on a dedicated page on the EMA website.