o

EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/285451/2015

EMEA/H/C/002749

EPAR summary for the public

Lumark

lutetium (¹⁷⁷Lu) chloride

This is a summary of the European public assessment report (EPAR) for Lumark. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Lumark.

For practical information about using Lumark, patients should read the package leaflet or contact their doctor or pharmacist.

What is Lumark and what is it used for?

Lumark contains the radioactive compound lutetium (¹⁷⁷Lu) chloride and is used for radiolabelling other medicines. Radiolabelling is a technique for tagging (or labelling) medicines with radioactive compounds so they can carry radioactivity to where it is needed in the body, for example the site of a tumour.

Lumark is not given to patients on its own; it is only to be used to radiolabel medicines that have been specifically developed for use with Lumark.

How is Lumark used?

Lumark is only used by specialists who have experience in radiolabelling.

Lumark is never given to a patient on its own. Radiolabelling with Lumark takes place in a laboratory setting. The radiolabelled medicine is then given to the patient according to the instructions in that medicine's product information.

How does Lumark work?

The active substance in Lumark, lutetium (¹⁷⁷Lu) chloride, is a radioactive compound that mainly emits a type of radiation known as beta radiation, with small amounts of gamma radiation. When a medicine

30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

© European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.

is radiolabelled with Lumark, the medicine carries the radiation to where it is needed in the body, either to kill cancer cells (when used for treatment) or to obtain images on a screen (when used in diagnosis).

What benefits of Lumark have been shown in studies?

Because the use of lutetium (¹⁷⁷Lu) to radiolabel medicines is well established, the company presented data from the scientific literature. Several published studies have established the usefulness of lutetium (¹⁷⁷Lu) in radiolabelling medicines for diagnosing and treating neuroendocrine tumours. This is a group of tumours that affect hormone-secreting cells in many parts of the body, including the pancreas, intestine, stomach and lungs.

The benefits of Lumark will largely depend on the medicine that it is used to radiolabel.

What are the risks associated with Lumark?

The side effects with Lumark depend largely on the medicine it is used with and will be described in that medicine's package leaflet. Lumark itself is radioactive, and as with any other radioactive product, its use may carry a risk of developing cancer and hereditary defects. However, the quantity of Lumark to be used is very small and therefore these risks are considered low. The doctor will ensure that the expected benefit to the patients of using Lumark outweigh the risks linked to the radioactivity.

Medicines radiolabeled with Lumark must not be used in pregnant women or women who may be pregnant. For the full list of all restrictions on the use of Lumark, see the package leaflet. Information on restrictions that apply specifically to medicines radiolabelled with Lumark will be found in the package leaflets of those medicines.

Why is Lumark approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the use of lutetium (¹⁷⁷Lu) for radiolabelling medicines was well established and well documented in the scientific literature. As with all radiolabelling materials for medicines, there are risks linked to radiation exposure from Lumark. Information on how to minimise the risks is included in the product information for Lumark.

The CHMP concluded that the benefits of Lumark outweigh the risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Lumark?

A risk management plan has been developed to ensure that Lumark is used as safely as possible.

Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Lumark, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Lumark

The European Commission granted a marketing authorisation valid throughout the European Union for Lumark on 19 June 2015.

The full EPAR and risk management plan summary for Lumark can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Lumark, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 06-2015.

Lumark

EMA/285451/2015

Page 3/3