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.

Clinical trial experience with sonidegib

Adverse reactions: clinical trial experience

Musculoskeletal and connective tissue disorders

Skin and subcutaneous tissue disorders

Nervous system disorders

Administration site reactions

Gastrointestinal disorders

Metabolism and nutrition

Key laboratory abnormalities

Long-term follow-up — clinical trial experience

Future directions for sonidegib

Related information

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