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Home » Topics A–Z » Key clinical-trial evidence for sonidegib
Author: Anoma Ranaweera, Medical Writer, Auckland, New Zealand; Chief Editor: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, August 2016.
In July 2015 the US FDA (Food and Drug Administration) approved sonidegib (Odomzo®; Novartis, New Jersey, USA) for the treatment of adult patients with locally advanced basal cell carcinoma (BCC).
The European Commission approved the use of sonidegib for basal cell carcinoma in August 2015. In June 2016, sonidegib was granted marketing authorisation in Switzerland for treatment of adults with advanced basal cell carcinoma. The drug is also approved in Australia but is not available in New Zealand as yet.
Sonidegib is an inhibitor of the Hedgehog pathway. It binds to and inhibits Smoothened, a transmembrane protein involved in Hedgehog signal transduction, which plays a critical role in stem cell maintenance and tissue repair.
Sonidegib is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
Advanced basal cell carcinoma
If you are not based in New Zealand, we suggest you refer to your national drug approval agency for further information about medicines (eg, the Australian Therapeutic Goods Administration and the US Food and Drug Administration) or a national or state-approved formulary (eg, the New Zealand Formulary and New Zealand Formulary for Children and the British National Formulary and British National Formulary for Children).
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