Javlor
Active
Substance: vinflunine
Common Name: vinflunine
ATC Code: L01CA05
Marketing Authorisation Holder: Pierre Fabre Médicament
Active Substance: vinflunine
Status: Authorised
Authorisation Date: 2009-09-21
Therapeutic Area: Carcinoma, Transitional Cell Urologic Neoplasms
Pharmacotherapeutic Group: Antineoplastic agents
Therapeutic
Indication
Javlor is
indicated in monotherapy for the treatment of adult patients with advanced or
metastatic transitional-cell carcinoma of the urothelial tract after failure of
a prior platinum-containing regimen.
Efficacy and
safety of vinflunine have not been studied in patients with performance status
≥ 2.
What is Javlor?
Javlor is a
concentrate for solution for infusion (drip into a vein). It contains the
active substance vinflunine (25 mg/l).
What is Javlor
used for?
Javlor is used
for the treatment of adults with advanced or metastatic ‘transitional-cell
carcinoma of the urothelial tract’ (a cancer that affects the lining of the
bladder and the rest of the urinary tract). ‘Metastatic’ means that the cancer
has spread to other parts of the body. Javlor is used when previous treatment
with a platinum-containing anticancer medicine has failed.
The medicine can
only be obtained with a prescription.
How is Javlor
used?
Treatment with
Javlor should be started under the supervision of a doctor qualified to use
anticancer medicines and is only given in specialised hospital units. Before
administering Javlor, patients should have a blood test to check their blood-cell
and haemoglobin levels. This is because low levels of haemoglobin (a protein
found in red blood cells that carries oxygen around the body) and blood cells
(white blood cells and platelets) are a frequent side effect of the medicine.
The dose of Javlor
to be given is based on the patient’s body surface area (calculated using
height and weight). The recommended dose is 320 mg per m2. Javlor is
given as a drip into a vein over a period of 20 minutes once every three weeks.
The doctor may need to adjust the dose by taking into account the patient’s
age, liver or kidney function and certain side effects that the patient may be
experiencing. The doctor may also delay or stop doses if the patient
experiences certain side effects, including low levels of platelets and
neutrophils (a type of white blood cell), and certain side effects affecting
the heart, liver or lungs. Measures to prevent constipation, such as laxatives,
are recommended after Javlor is given in the first week.
For more
information, see the summary of product characteristics (also part of the
EPAR).
How does Javlor
work?
The active
substance in Javlor, vinflunine, belongs to the group of anticancer medicines
known as the vinca alkaloids. It attaches to a protein in cells called
‘tubulin’, which is important in the formation of the internal ‘skeleton’ that
cells need to assemble when they divide. By attaching to tubulin in cancer
cells, vinflunine stops the formation of the skeleton, preventing the division
and spread of the cancer cells.
How has Javlor
been studied?
In one main
study of 370 adults with advanced or metastatic transitional-cell carcinoma of
the urothelial tract, patients who were given Javlor treatment were compared
with patients who were not given any anticancer medicine. During the study all
patients received best supportive care (any medicines or techniques to help
patients, but not other anticancer medicines). All the patients had previously
received treatment with a platinum-containing medicine which failed. The main
measure of effectiveness was how long the patients lived. The study also looked
separately at the results in eligible patients who fulfilled strict criteria
such as having had a worsening of the disease after treatment with a
platinum-containing medicine.
What benefit has
Javlor shown during the studies?
Javlor with best
supportive care was more effective than best supportive care alone in
prolonging the lives of patients with advanced or metastatic transitional-cell
carcinoma of the urothelial tract. Among all patients in the study, there was
no clear evidence of a difference in survival between patients who received
Javlor and those who did not. However, there was a difference among patients
who fulfilled the strict criteria entry requirements for the study. In this
group, those given Javlor lived for 6.9 months compared with 4.3 months for
patients who were not given the Javlor.
What is the risk
associated with Javlor?
The most common
side effects with Javlor (seen in more than 1 patient in 10) are neutropenia,
leucopenia (low white-blood-cell counts), anaemia (low red-blood-cell counts),
thrombocytopenia (low platelet counts), loss of appetite, constipation,
abdominal (stomach) pain, vomiting, nausea (feeling sick), stomatitis
(inflammation of the lining of the mouth), diarrhoea, alopecia (hair loss),
myalgia (muscle pain), asthenia (weakness) or fatigue (tiredness),
injection-site reactions, fever and weight loss. For the full list of all side
effects reported with Javlor, see the package leaflet.
Javlor must not
be used in people who are hypersensitive (allergic) to vinflunine or other
vinca alkaloids. It must not be used in patients who have or have had a severe
infection within the past two weeks or in patients with a neutrophil count of
less than 1,500 per mm3 for the first administration or less
than 1,000 per mm3 for subsequent administrations, or a
platelet count less than 100,000 per mm3. It must also not be used
in breastfeeding mothers.
Why has Javlor
been approved?
The CHMP decided
that Javlor’s benefits are greater than its risks and recommended that Javlor
be given marketing authorisation.
Other
information about Javlor
The European
Commission granted a marketing authorisation valid throughout the European
Union for Javlor on 21 September 2009.
For more
information about treatment with Javlor, read the package leaflet (also part of
the EPAR) or contact your doctor or pharmacist.
Source: European
Medicines Agency
