Active Substance: vismodegib
Common Name: vismodegib
ATC Code: L01XX43
Marketing Authorisation Holder: Roche Registration Ltd
Active Substance: vismodegib
Authorisation Date: 2013-07-12
Therapeutic Area: Carcinoma, Basal Cell
Pharmacotherapeutic Group: Antineoplastic agents
Treatment of advanced basal-cell carcinoma
What is Erivedge and what is it used for?
Erivedge is a cancer medicine that contains the active substance vismodegib. It is used to treat adults with basal cell carcinoma (a slow-growing form of skin cancer) in advanced stages: when the cancer is metastatic (has spread to other parts of the body) and is causing symptoms, or when it is locally advanced (has started to spread to nearby areas) and is not suitable for surgery or radiotherapy (treatment with radiation).
How is Erivedge used?
Erivedge can only be obtained with a prescription. It should only be prescribed by or under the supervision of a specialist doctor experienced in managing basal-cell carcinoma. It is available as capsules (150 mg). The recommended dose is one capsule once a day. The benefits of continuing treatment should be regularly assessed and the best duration of treatment will vary based on the benefit and side effects experienced by each patient. For further information, see the package leaflet.
How does Erivedge work?
The active substance in Erivedge, vismodegib, acts by disrupting the so-called ‘Hedgehog signalling pathway’, which is normally involved in regulating the early cell-development stages of unborn babies and in certain cell processes in adults. In basal cell carcinoma, the Hedgehog signalling pathway becomes abnormally active and leads to the growth and spread of the cancerous cells. Vismodegib attaches to a protein called ‘SMO’, which is involved in activating the Hedgehog signalling pathway. By attaching to SMO, vismodegib blocks this pathway, thereby slowing down the growth and spread of the cancer cells in basal cell carcinoma.
What benefits of Erivedge have been shown in studies?
Erivedge was studied in one main study involving 104 patients with either metastatic or locally advanced basal-cell carcinoma. The patients were given Erivedge until their disease got worse or they could no longer tolerate treatment or withdrew from the study. Erivedge was not compared with any other treatment. The main measure of effectiveness was the response to treatment, based on reduction by at least 30% in tumour size or disappearance of all signs of cancer (the objective response rate). Around 33% (11 out of 33) of patients with metastatic disease and 48% (30 out of 63) of patients with locally advanced disease responded to treatment.
What are the risks associated with Erivedge?
The most common side effects with Erivedge (seen in more than 3 in 10 people) are muscle spasms, alopecia (hair loss), dysgeusia (taste disturbances), weight loss, fatigue (tiredness), nausea (feeling sick) and diarrhoea. For the full list of all side effects reported with Erivedge, see the package leaflet.
Erivedge must not be used in women who are pregnant or breast-feeding, or who could potentially have children and do not comply with the special pregnancy prevention programme for Erivedge. It must not be used together with St John’s wort (a herbal medicine used to treat depression). For the full list of restrictions, see the package leaflet.
Why is Erivedge 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 shown for patients with locally advanced and metastatic disease. It also considered that the side effects were manageable, although the data on patients with metastatic disease were limited. Since Erivedge disrupts the mechanism involved in the early development stages of unborn babies, the CHMP concluded that appropriate measures were needed for both men and women treated with Erivedge to prevent pregnancy during and after stopping treatment.
Erivedge has been given ‘conditional approval’. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.
What information is still awaited for Erivedge?
Since Erivedge has been granted a conditional approval, the company that markets Erivedge 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?
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 implement a pregnancy-prevention programme, by providing educational materials on the risks to the unborn baby, including a reminder card, to patients and healthcare professionals who are expected to prescribe and dispense Erivedge. The company will report any pregnancies that occur during treatment with Erivedge and will monitor their outcome.
Other information about Erivedge
The European Commission granted a marketing authorisation valid throughout the European Union for Erivedge on 12 July 2013.
For more information about treatment with Erivedge, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Source: European Medicines Agency
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