What is Erivedge - vismodegib used for and what is it used for?
Erivedge is a cancer treatment medicine that contains the active substance vismodegib . It is indicated for the treatment of adult patients with basal cell carcinoma (a slow-growing form of skin cancer) in advanced stages when the tumor is metastatic (has spread to other parts of the body) and is the cause of symptoms or when it is locally advanced (ie started spreading to nearby areas) and it is not considered appropriate to proceed with surgery or radiotherapy (radiation treatment).
How is Erivedge - vismodegib used?
Erivedge can only be obtained with a prescription. It should only be prescribed by a specialist doctor experienced in the management of basal cell carcinoma or under the supervision of such doctor. The medicine is available as capsules (150 mg). The recommended dose is one capsule once a day. The benefit of continued treatment must be regularly verified and the optimal duration of therapy will depend on the benefit and side effects reported by each patient. For more information, see the package leaflet.
How does Erivedge - vismodegib work?
The active ingredient in Erivedge, vismodegib, acts by inhibiting the so-called "Hedgehog signaling pathway", which usually contributes to the regulation of early stages of cell development in the fetus and to certain cellular processes in adults. In basal cell carcinoma, the Hedgehog signaling pathway becomes unusually active and determines the growth and spread of cancer cells. Vismodegib binds to a protein called "SMO", which is involved in activating the Hedgehog signaling pathway. By binding to SMO, vismodegib blocks this pathway and slows the growth and spread of cancer cells in basal cell carcinoma.
What benefit has Erivedge - vismodegib shown during the studies?
Erivedge has been studied in one main study involving 104 patients with metastatic or locally advanced basal cell carcinoma. Patients were treated with Erivedge until the disease worsened or until they could no longer tolerate therapy or even retired from the study. Erivedge has not been compared with another treatment. The main measure of effectiveness was the response to treatment, based on a reduction of at least 30% of the tumor mass or on the disappearance of all signs of the tumor (the objective response rate). Approximately 33% (11 of 33) of patients with metastatic cancer and 48% (30 of 63) of patients with locally advanced cancer responded to the therapy.
What is the risk associated with Erivedge - vismodegib?
The most common side effects of Erivedge (which may affect more than 3 in 10 people) are muscle spasms, alopecia (hair loss), dysgeusia (taste disorder), weight loss, fatigue, nausea and diarrhea. For the full list of all side effects reported with Erivedge, see the package leaflet. Erivedge should not be used in women who are pregnant or breastfeeding, or in patients of childbearing age who do not adhere to the specific pregnancy prevention program developed for Erivedge. It must not be given in combination with products containing St. John's wort (a herbal medicine used in the treatment of depression). For the full list of limitations, see the package leaflet.
Why has Erivedge - vismodegib been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Erivedge's benefits are greater than its risks and recommended that it be approved for use in the EU. The committee considered that the benefits of Erivedge had been demonstrated in patients with locally advanced and metastatic cancer. It also took into account the fact that undesirable effects are manageable, although data on patients with metastatic cancer are limited. Since Erivedge interrupts the mechanism involved in the early stages of fetal development, the CHMP concluded that appropriate pregnancy prevention measures should be taken during treatment and after its discontinuation in both male and female patients treated with Erivedge. Erivedge has obtained a "conditional approval". This means that further information on the medicine, which the company is required to provide, will be available in the future. Every year the European Medicines Agency will review the new information available and this summary will be updated accordingly.
What information is still awaited for Erivedge - vismodegib?
Since a conditional approval has been issued for Erivedge, the company that markets it will provide the results of a large safety study in patients with metastatic disease.
What measures are being taken to ensure the safe and effective use of Erivedge - vismodegib?
A risk management plan has been developed to ensure that Erivedge 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 Erivedge, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company will develop a pregnancy prevention program by preparing information materials on the risks to the fetus, including a reminder, for patients and healthcare professionals who can prescribe and distribute Erivedge. The company will report on any pregnancies that occur during Erivedge therapy and will monitor the outcome.
Other information on Erivedge - vismodegib
On 12 July 2013, the European Commission issued a marketing authorization for Erivedge, valid throughout the European Union. For more information about treatment with Erivedge, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 01-2015.
