LEDAGA®

Ledaga can only be obtained with a prescription. Treatment with Ledaga should be started by a doctor with appropriate experience.

Ledaga, which is available as a gel, is applied as a thin film to the affected areas of the skin once a day. It has to be applied with care to stop it getting on areas not affected by the disease. Treatment should be stopped if patients develop blisters or open sores. For further information, see the package leaflet.

The active substance in Ledaga, chlormethine, belongs to the group of cancer medicines called ‘alkylating agents’. Alkylating agents work by attaching to the DNA of cells while the cells are dividing. As a result, cancer cells cannot divide and they eventually die.

The company provided data from the published literature showing that chlormethine, the active substance in Ledaga, is effective in treating mycosis fungoides-type cutaneous T-cell lymphoma.

In addition, a study involving 260 patients found that Ledaga was at least as effective as an ointment containing the same amount of chlormethine. The ointment’s effectiveness was considered comparable to that of the reference medicine, Caryolysine. Effectiveness was measured as complete or partial improvement in the ‘CAILS’ score, which takes into account different features of the cancer, such as the size and appearance of the skin damage. Ledaga was effective in 58% of patients (76 patients out of 130) after at least 6 months of treatment compared with 48% of patients (62 out of 130) using the ointment.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Ledaga has shown comparable safety and effectiveness to Caryolysine and has shown satisfactory quality. Therefore, the CHMP’s view was that, as for Caryolysine, the benefits outweigh the identified risks. The Committee recommended that Ledaga be approved for use in the EU.

The company that markets Ledaga will supply materials to prevent accidental contact with the medicine, especially in the eye and the inside of the nose and mouth. The materials will include a sealable, child-resistant plastic bag for safely storing the medicine in a refrigerator, together with a patient alert card with instructions on the correct way to apply the medicine.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ledaga have also been included in the summary of product characteristics and the package leaflet.

The European Commission granted a marketing authorisation valid throughout the European Union for Ledaga on 3 March 2017.

For more information about treatment with Ledaga, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.