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EMA Suspends Ingenol Mebutate as a Precaution While Review of Skin Cancer Risk Continues

Higher incidence of skin malignancy with ingenol mebutate than with imiquimod
30 Jan 2020
Melanoma and other skin tumours

On 17 January 2020, the European Medicines Agency (EMA) recommended that patients stop using ingenol mebutate (Picato), a gel for treating the skin condition actinic keratosis, while it continues its review of the medicine’s safety.

EMA’s Pharmacovigilance Risk Assessment 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 has 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.

Information for 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.

Picato is available as a gel which is applied to skin areas affected by actinic keratosis. It is used when the outer layer of the affected skin is not thickened or raised. Actinic keratosis is caused by too much sunlight exposure and can turn into skin cancer.

Picato has been authorised for use in the EU since November 2012.

The review of Picato has been initiated at the request of the European Commission (EC). While the review is ongoing, the PRAC has recommended suspending the medicine as an interim measure to protect public health. The recommendation will be forwarded to the EC, which will issue a provisional legally binding decision applicable in all EU Members States.

Once the PRAC review is concluded, the final recommendations will be forwarded to the EMA’s Committee for Medicinal Products for Human Use, responsible for questions concerning medicines for human use, which will adopt an opinion. The final stage of the review procedure is the adoption by the EC of a legally binding decision applicable in all EU Member States.

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