Author: Anoma Ranaweera, Staff Writer, 2012. DermNet NZ Editor in Chief: Adjunct A/Prof Amanda Oakley, Dermatologist, Hamilton, New Zealand. Updated June 2018. Copy edited by Gus Mitchell.
Basal cell carcinoma (BCC) is usually curable if the lesions are restricted to a small area of the skin. However, in rare cases, the lesions can become disfiguring, invade surrounding tissue, or metastasize. In these instances of advanced BCC, the disease cannot be effectively treated with the standard treatments of surgery or radiation.
On January 30, 2012, the US Food and Drugs Administration (FDA) approved vismodegib (Erivedge®, made by Genentech, Inc. USA) for the treatment of adults with metastatic basal cell carcinoma. It is not currently funded by PHARMAC in New Zealand (Aug 2016).
Vismodegib is intended for use in adult patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and patients whose cancer has metastasized.
This is the first FDA-approved drug for use in advanced forms of BCC, one of the most common skin cancers.
The most common adverse reactions (having an incidence of 10% or more) associated with vismodegib in clinical trials are:
The following adverse drug reactions have been identified during post-approval use of vismodegib based on case reports and Investigator Initiated Studies:
In a study in 60 healthy subjects, therapeutic doses of vismodegib did not have a significant effect on the QTc interval (a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle).
Roche and Genentech are currently evaluating vismodegib in a phase 2 trial for patients with operable forms of BCC.
New Zealand approved datasheets are the official source of information for these prescription medicines, including approved uses and risk information. Check the individual New Zealand datasheet on the Medsafe website.
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