EMEA/H/C/326

EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)

TARGRETIN

EPAR summary for the public

What is Targretin?

Targretin is a medicine containing the active substance bexarotene. It is available as white soft capsules (75 mg).

What is Targretin used for?

Targretin is used for the treatment of the visible signs on the skin of cutaneous T-cell lymphoma (CTCL). CTCL is a rare type of lymphoma (cancer of the lymph tissue) where some white blood cells (T-cells) grow in the skin. Targretin is used in patients who have an advanced disease and have failed to respond to at least one other treatment.

The medicine can only be obtained with a prescription.

How is Targretin used?

Treatment with Targretin should only be initiated and maintained by a doctor who has experience in the treatment of patients with CTCL. The dose of Targretin is based on the patient’s body surface area in square metres (m²). The recommended starting dose is 300 mg/m²/day. The dose is adjusted depending on the patient’s response to treatment or side effects. Treatment should continue as long as the patient gets a benefit from it. See the Summary of Product Characteristics, also part of the EPAR, for full details.

Targretin capsules should be taken as a single dose once a day with a meal.

How does Targretin work?

The active substance in Targretin, bexarotene, is an anticancer agent. It belongs to the group of retinoids, substances that are derived from vitamin A. The exact way bexarotene works in CTCL is not known.

How has Targretin been studied?

The effectiveness of Targretin has been examined in two studies involving a total of 193 patients with CTCL who had failed on at least two previous treatments. The studies did not include a control group (Targetin was not compared to another medicine or to placebo). Ninety-three of these patients had advanced disease that had not responded to other treatment. Sixty-one patients were treated at the starting dose of 300 mg/m²/day. The main measure of

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©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged effectiveness was the response to treatment after 16 weeks. This was measured by the doctor’s grading of improvement, as well as by a score of 5 clinical signs (area of skin affected, redness, raised areas, scale-like skin and colour).

What benefit has Targretin shown during the studies?

Across the two studies, among the patients who received 300 mg/m², about half of them responded to treatment, according the doctor’s grading. The response rates according to the 5 skin scores were 36% and 27%, respectively.

What is the risk associated with Targretin?

The most common side effects seen with Targretin (in more than 1 patient in 10) are leucopenia (reduced white cell count), hypothyroidism (underactive thyroid gland), hyperlipaemia (high levels of fats in the blood), hypercholesterolaemia (high blood cholesterol), exfoliative dermatitis (skin peeling), pruritus (itching), rash, pain, asthenia (weakness). For the full list of all side effects reported with Targretin,

Package Leaflet.

Targretin should not be used in people who may be hypersensitive (allergic) to any of the other ingredients. Targretin should also not be used in the following

•    women who are pregnant or breast-feeding

•    women who could become pregnant

•    anyone who has had pancreatitis (inflammation of the pancreas)

•    uncontrolled hypercholesterolaemia (high blood cholesterol).

•    uncontrolled hypertriglyceridaemia (high blood triglycerides [fat]).

•    hypervitaminosis A (high levels of vitamin A)

•    uncontrolled thyroid disease.

•    liver disease

•    where there is a body infection.

Why has Targretin been approved?

The Committee for Medicinal products for Human Use (CHMP) decided that Targretin’s benefits are greater than its risks for the treatment of the skin manifestations of advanced stage cutaneous T-cell lymphoma patients refractory to at least one systemic treatment. They recommended that Targretin be given marketing authorisation.

Other information about Targretin:

The European Commission granted a marketing authorisation valid throughout the European Union, for Targretin on 29 March 2001. The marketing authorisation was renewed on 29 March 2006. The marketing authorisation holder is Eisai Ltd.

The full EPAR for Targretin is available here.

This summary was last updated in 03-2007.

©EMEA 2007