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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/349074/2013

EMEA/H/C/002556

EPAR summary for the public

Lonquex

lipegfilg rastim

This is a summary of the European public assessment report (EPAR) for Lonquex. 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 Lonquex.

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

What is Lonquex and what is it used for?

Lonquex is a medicine that contains the active substance lipegfilgrastim. It is used to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in adult cancer patients receiving cytotoxic chemotherapy.

Cytotoxic chemotherapy (medicines that kill fast growing cells) commonly causes neutropenia because in addition to cancer cells it also kills other fast growing cells such as neutrophils, leaving the patient at risk of infections.

Lonquex is not used in patients receiving chemotherapy for chronic myeloid leukaemia (a cancer of the white blood cells) and myelodysplastic syndromes (a disease that can develop into a leukaemia).

How is Lonquex used?

Lonquex is available as a solution for injection in pre-filled syringes. The injections should be given under the skin in the abdomen, upper arm or thigh. One 6-mg dose is given in each chemotherapy cycle around 24 hours after chemotherapy treatment.

The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in treating cancer and blood disorders. Well-motivated patients may be able to self-administer the medicine once they have been properly trained but the first injection should be done under the direct supervision of a doctor. For more information, see the package leaflet.

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© European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.

How does Lonquex work?

The active substance in Lonquex, lipegfilgrastim, is similar to granulocyte colony stimulating factor (G-CSF), a naturally occurring protein in the body that promotes the production of white blood cells including neutrophils in the bone marrow. Lipegfilgrastim acts in the same way as naturally produced G-CSF, increasing the production of neutrophils and thereby helping to reduce the duration of neutropenia and to prevent febrile neutropenia (a sign of infection) in patients undergoing chemotherapy.

Lipegfilgrastim is similar to filgrastim, which has been available in the European Union (EU) for a number of years. In Lonquex, the filgrastim has been 'pegylated' (attached to a chemical called polyethylene glycol). This decreases the rate at which filgrastim is removed from the body and allows the medicine to be given less often. The filgrastim in Lonquex is produced by a method known as 'recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced that makes the bacteria able to produce the filgrastim protein.

What benefits of Lonquex have been shown in studies?

Lonquex has been shown to be effective in reducing the duration of neutropenia and the number of febrile neutropenia cases among patients undergoing chemotherapy. In a main study in 202 breast cancer patients Lonquex compared well with another pegylated filgrastim: the average duration of severe neutropenia during chemotherapy was 0.7 days (around 17 hours) with Lonquex compared with 0.8 days (around 19 hours) with the other medicine. Lonquex also compared well with the other medicine in the number of febrile neutropenia cases: 1 in the Lonquex-treated group versus 3 in the comparator group.

In another main study in 376 patients with lung cancer, treatment with Lonquex was superior to placebo (a dummy treatment) in reducing the time it took to recover from neutropenia as well as the occurrence and duration of severe neutropenia.

What are the risks associated with Lonquex?

The most common side effects with Lonquex (which may affect more than 1 in 10 patients) are bone and muscle pain, which are generally mild to moderate in severity and can be treated with standard painkillers. For the full list of all side effects reported with Lonquex, see the package leaflet.

Why is Lonquex approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that the studies had shown that Lonquex is effective in reducing the duration of severe neutropenia and the number of febrile neutropenia cases. The side effects seen with the medicine were typical for this class of medicines and are considered manageable. The CHMP therefore concluded the benefits of Lonquex outweigh its risks and recommended that it be approved for use in the EU.

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

A risk management plan has been developed to ensure that Lonquex 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 Lonquex, including the appropriate precautions to be followed by healthcare professionals and patients.

Lonquex

In addition, the company that markets the medicine will carry out a study to further investigate the effects of Lonquex on the patients' cancer - the possibility of cancer worsening during treatment with G-CSF medicines was a concern raised during the evaluation of the medicine though this was not established. The company will also provide data on the potential side effects in children under 18 years of age including the immune reactions.

Other information about Lonquex

The European Commission granted a marketing authorisation valid throughout the European Union for Lonquex on 25 July 2013.

The full EPAR for Lonquex can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.

This summary was last updated in 07-2013.

Lonquex

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