Regulatory Focus™ > News Articles > 2019 > 9 > EMA Begins Review of Skin Cancer Data for Patients Using Picato

EMA Begins Review of Skin Cancer Data for Patients Using Picato

Posted 06 September 2019 | By Zachary Brennan 

EMA Begins Review of Skin Cancer Data for Patients Using Picato

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) on Friday announced that it’s begun reviewing data on skin cancer in patients using Picato (ingenol mebutate), a gel for treating actinic keratosis, which is a skin condition caused by excessive sun exposure.

The review, which will run until January 2020, was triggered by data from several studies showing a higher number of skin cancer cases including cases of squamous cell carcinoma in patients using Picato, EMA said.

PRAC is calling on LEO Pharma to provide information on the cumulative patient exposure to Picato around the world, cumulative reviews of all cases of skin tumors observed in clinical studies with the gel, a cumulative review of all cases of skin tumors observed in the post-market setting and cumulative reviews of all cases of skin tumors observed in studies with the related ester ingenol disoxate. PRAC is also seeking further information on why LEO prematurely halted a study on ingenol disoxate.

A previously requested meta-analysis of four studies on ingenol disoxate “found a marked increase in skin tumours in the group of active treatment compared to placebo,” according to the referral to PRAC.

“Please provide a critical review of all available evidence, including non-clinical data, in relation to any mechanism by which Picato could lead to rapidly accelerated growth or increased incidence of tumours,” PRAC told LEO.

The committee also said it will assess the impact of the data on the benefit-risk balance of Picato and recommend whether the medicine’s EU marketing authorization should be amended.

“Healthcare professionals are advised to use Picato with caution in patients who have had skin cancer in the past. In addition, patients should continue to watch out for any skin lesions and inform their doctor immediately if they notice anything unusual,” the agency says.

EMA

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe