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Updated: Dec 24, 2025
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Published on: August 21, 2013
Sonidegib: Safety and Efficacy in Treatment of Advanced Basal Cell Carcinoma
Alessia Villani1, Gabriella Fabbrocini2, Claudia Costa2
1Dermatology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy. ali.vil@hotmail.it.
Abstract:
Hedgehog inhibitors are promising alternative treatments for patients with advanced basal cell carcinomas. Sonidegib (Odomzo®), an oral smoothened (SMO) antagonist, is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) who present recurrence following surgery or radiation therapy, or those who are not candidates for surgery or radiotherapy. Several studies and randomized controlled trials have been conducted to evaluate the efficacy, safety, and tolerability of this new molecule that has demonstrated a good response rate (44%). Grade 1-2 adverse events have also been reported. Further studies of real-world experiences are needed to better understand the correct management of the drug, alternative dosing regimens, and differences with other hedgehog inhibitors. This article provides a complete overview of the pharmacology and pharmacokinetics of sonidegib and a report of the trials and studies conducted. The most frequent adverse events and their correct management are also discussed.
Insights
Sonidegib is an effective hedgehog inhibitor for advanced basal cell carcinoma, showing a 44% response rate with manageable side effects. Further real-world studies are needed to optimize its use.
Area of Science:
- Oncology
- Dermatology
- Pharmacology
Background:
- Advanced basal cell carcinoma (BCC) poses treatment challenges.
- Hedgehog pathway inhibitors offer a novel therapeutic approach.
- Sonidegib is an oral smoothened (SMO) antagonist for locally advanced BCC (laBCC).
Purpose of the Study:
- To provide a comprehensive overview of sonidegib's pharmacology and pharmacokinetics.
- To review clinical trial data on sonidegib's efficacy and safety.
- To discuss adverse event management and future research directions.
Main Methods:
- Review of published studies and randomized controlled trials.
- Analysis of sonidegib's pharmacological and pharmacokinetic properties.
- Evaluation of clinical efficacy, safety, and tolerability data.
Main Results:
- Sonidegib demonstrated a 44% response rate in patients with laBCC.
- Common adverse events were generally Grade 1-2 and manageable.
- The drug is indicated for recurrent or non-surgical/radiotherapy candidates.
Conclusions:
- Sonidegib is a promising treatment option for advanced BCC.
- Understanding real-world experience is crucial for optimizing drug management.
- Further research is warranted to explore dosing and comparative effectiveness.
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