Lonquex
Active
Substance: lipegfilgrastim
Common Name: lipegfilgrastim
ATC Code: L03AA14
Marketing Authorisation Holder: Sicor Biotech UAB
Active Substance: lipegfilgrastim
Status: Authorised
Authorisation Date: 2013-07-25
Therapeutic Area: Neutropenia
Pharmacotherapeutic Group: Immunostimulants, colony-stimulating
factors
Therapeutic
Indication
Reduction in the
duration of neutropenia and the incidence of febrile neutropenia in adult
patients treated with cytotoxic chemotherapy for malignancy (with the exception
of chronic myeloid leukaemia and myelodysplastic syndromes).
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) or myelodysplastic syndromes (a disease that can
develop into a leukaemia).
How is Lonquex
used?
Lonquex is
available as a solution for injection in prefilled 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.
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 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.
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.
Source: European
Medicines Agency
