What is Javlor?
Javlor is a concentrate for solution for intravenous infusion (drip into a vein). The solution contains the active substance vinflunine (25 mg / l).
What is Javlor used for?
Javlor is indicated for the treatment of adult patients with "transitional cell carcinoma of the urothelial tract" (a tumor that affects the lining of the bladder and the rest of the urinary tract) of advanced or metastatic stage. The term "metastatic" indicates that the tumor has spread to other parts of the body. Javlor is used if previous treatment with a platinum-containing cancer medicine has failed.
The medicine can only be obtained with a prescription.
How is Javlor used?
Treatment with Javlor must be started under the responsibility of a qualified doctor in the use of anticancer drugs. Before the administration the patient must take a blood test to check the concentrations of neutrophils, a type of white blood cell. This is because a frequent side effect of the medicine is neutropenia (ie a low concentration of neutrophils in the blood).
The dose of Javlor to be administered depends on the patient's body surface area, measured by height and weight. The recommended starting dose is 320 mg / m3. Javlor is administered by intravenous infusion lasting 20 minutes every three weeks. The doctor can adjust the dose according to the patient's general health conditions, considering the previous treatment and the presence or absence of neutropenia or problems with the liver or kidneys.
How does Javlor work?
The active substance in Javlor, vinflunine, belongs to the group of anticancer drugs known as vinca alkaloids. It binds to a protein found in cells ("tubulin") that is important in forming the internal "skeleton" that cells use to reconstitute themselves when they divide.
By adhering to tubulin in cancer cells, vinflunine blocks the formation of the skeleton, preventing the division and proliferation of cancer cells.
What studies have been carried out on Javlor?
The effects of Javrol were first tested in experimental models before being studied in humans.
In a main study of 370 adults with transitional cell carcinoma of the urothelial tract, patients receiving Javlor therapy were compared with subjects who were not given any anticancer medicine. During the study, all patients received them
best supportive care (any medicine or technique to help patients, but no other anticancer drugs). All patients were previously treated with a platinum-containing regimen without a positive result. The main measure of effectiveness was the survival time of the patients. The study also examined separately the results observed in patients who met strict criteria such as having registered a worsening of the
disease after therapy with the platinum-containing drug.
What benefit has Javlor shown during the studies?
Javlor in combination with the best supportive care has proved more effective than the best supportive care only in prolonging the survival of patients with advanced or metastatic transitional cell carcinoma of the urothelial tract. Among all the subjects who participated in the study, there was no evidence of a difference in survival between patients treated with Javlor and those not treated with the medicine. However, a difference was observed between patients who met the rigorous recruitment requirements for the study. In this group of people the subjects treated with Javlor survived 6.9 months compared to the 4.3 months of survival of patients who had not received the drug.
What is the risk associated with Javlor?
The most common side effects of Javlor (seen in more than 1 patient in 10) are neutropenia, leukopenia (decrease in the number of white blood cells), anemia (decrease in the number of globulirossi), thrombocytopenia (reduction in blood platelets), lack of appetite, peripheral sensory neuropathy (damage to peripheral nerves - ie external to the brain and spinal cord, with consequent reduction in sensitivity), constipation, abdominal pain, vomiting, nausea, stomatitis (inflammation of the mucous membranes of the oral cavity), diarrhea, alopecia (hair loss), myalgia (muscle pain), asthenia (loss of strength and energy), reactions at the injection site, fever and weight loss. For the full list of all side effects reported with Javlor, see the Package Leaflet.
Javlor should not be used in people who may be hypersensitive (allergic) to vinflunine or other vinca alkaloids. It must also not be used in patients who have or have had a severe infection in the last two weeks or in subjects with a number of neutrophils less than 1 500 per mm3 or a number of platelets less than 100 000 per mm3. The use of Javlor is not indicated during breastfeeding.
Why has Javlor been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Javlor's benefits are greater than its risks for the treatment of advanced or metastatic transitional cell carcinoma of the urothelial tract after the failure of a previous platinum-containing regimen. The committee recommended that Javlor be given marketing authorization.
More information on Javlor:
On 21 September 2009, the European Commission granted Javlor a marketing authorization valid for Pierre Fabre Médicament, valid throughout the European Union.
For the full EPPAR version of Javlor, click here.
Last update of this summary: 07-2009.
