What is Kisplyx - Lenvatinib used for and what is it used for?
Kisplyx is an anticancer medicine used to treat adult patients with advanced renal cell carcinoma (a type of kidney cancer) who have previously been treated with another anticancer called "vascular endothelial growth factor (VEGF) inhibitor".
Kisplyx is used in combination with another anticancer medicine called everolimus. Kisplyx contains the active ingredient lenvatinib.
How is Kisplyx - Lenvatinib used?
Kisplyx can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of anticancer medicines.
Kisplyx is available as capsules (4 mg and 10 mg). The recommended dose is 18 mg (obtained by administering one 10 mg capsule and two 4 mg capsules), once a day, at the same time every day, in combination with 5 mg everolimus once a day. It may be necessary to reduce the dose or to temporarily stop treatment with Kisplyx if certain side effects occur. Treatment should continue until the patient benefits or until the side effects become unsustainable. The dose of Kisplyx should be decreased in patients with severe renal or hepatic impairment.
For more information, see the package leaflet for Kisplyx and the everolimus-containing medicine.
How does Kisplyx - Lenvatinib work?
The active substance in Kisplyx, lenvatinib, is a tyrosine kinase inhibitor. This means that it blocks the activity of enzymes known as tyrosine kinases. These enzymes can be found in some receptors (such as VEGF, FGFR, PDGF, KIT and RET receptors) in cancer cells, where they activate different processes, including cell division and the growth of new blood vessels. By blocking these enzymes, lenvatinib is able to prevent the formation of new blood vessels, thus interrupting the blood supply that supports the growth of cancer cells and reducing tumor growth.
What benefit has Kisplyx - Lenvatinib shown during the studies?
Kisplyx activity was evaluated in a main study involving 153 adult patients with advanced renal cell carcinoma, who had shown a worsening of the disease despite treatment with a VEGF inhibitor. The study compared the association of Kisplyx and everolimus with Kisplyx alone or everolimus alone. The main measure of effectiveness was the patient's survival period without the disease getting worse (progression-free survival). Patients who had taken the combination of Kisplyx and everolimus lived on average 14.6 months without showing a worsening of the disease, compared to 7.4 months for patients who had only taken Kisplyx and 5.5 months of those who had taken only everolimus.
What are the risks associated with Kisplyx - Lenvatinib?
The most common side effects with Kisplyx (which may affect more than 3 in 10 people), whether used in combination with everolimus or in monotherapy, are diarrhea, hypertension, fatigue, loss of appetite and weight, vomiting, nausea, proteinuria (presence of protein in urine), stomatitis (inflammation of the mucous membrane of the mouth), headache, dysphonia (voice disorder), palmar-plantar erythrodysaesthesia syndrome (also called hand-foot syndrome, which is manifested by rash and numbness palms of the hands and soles of the feet), peripheral edema (swelling, particularly in the ankles and feet) and hypercholesterolemia (cholesterol levels [a type of lipid] elevated in the blood).
The main serious side effects are kidney failure and impaired renal function; cardiac and circulation disorders, such as heart failure and formation of blood clots in the arteries, which cause stroke or heart attack; cerebral hemorrhage or hemorrhage of a tumor inside the skull; one known as "reversible posterior encephalopathy syndrome", characterized by headache, confusion, seizures and vision loss; liver failure. For the full list of all side effects reported with Kisplyx, see the package leaflet. For the full list of all side effects reported with everolimus, see the package leaflet for the medicine that contains it.
The use of Kisplyx is contraindicated in breastfeeding women. For the full list of limitations, see the package leaflet.
Why has Kisplyx - Lenvatinib been approved?
Patients with advanced renal cell carcinoma previously treated have negative outcomes and major unmet medical needs. Kisplyx, used in combination with everolimus, has been shown to significantly increase the period without the disease getting worse. The safety profile of Kisplyx in combination with everolimus is similar to that of the two medicines used as monotherapy and side effects are considered manageable. The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Kisplyx's benefits are greater than 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 Kisplyx - Lenvatinib?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kisplyx have been included in the summary of product characteristics and the package leaflet.
Other information on Kisplyx - Lenvatinib
The full EPAR for Kisplyx can be found on the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Kisplyx therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
