Efficacy and safety of sonidegib for the management of basal cell carcinoma: a drug safety evaluation

ABSTRACT

Introduction

Surgery is the standard management for most of basal cell carcinomas (BBCs). In some cases, also radiotherapy may be a valuable weapon as well as ablative and topical treatments. However, all these approaches may be limited by some tumor features. In this scenario, locally advanced BCCs (laBCC) and metastatic BCC, also defined as ‘difficult-to-treat’ BCC, remain the real treatment challenge. New knowledge on BCC pathogenesis, particularly the Hedgehog (HH) pathway, led to the development of new selective therapies such as vismodegib and sonidegib. In particular, sonidegib is an orally administered small molecules, which inhibits the HH signaling pathway through the binding to SMO receptor, recently approved for the management of adult patients with laBCC who are not amenable to curative surgery or radiation therapy.

Areas covered

The purpose of this review is to analyze and discuss the efficacy and safety of sonidegib for the management of BCC, to provide a broad perspective on the currently available data.

Expert opinion

Sonidegib is a valuable weapon for the management of difficult-to-treat BCC. Current data showed promising results in terms of effectiveness and safety. However, more studies are needed to underline its role in BCC management, also considering the presence of vismodegib, and to investigate its use in a long-term period.

KEYWORDS:

• Sonidegib
• basal cell carcinoma
• skin cancer
• Hedgehog pathway
• treatment

Declaration of Interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Author contribution statement

A Villani: data curation, formal analysis, investigation, visualization, writing-original draft preparation, writing – review & editing. M Scalvenzi: data curation, formal analysis, investigation, visualization, writing-original draft preparation, writing – review & editing. G Micali: data curation, formal analysis, investigation, visualization, writing-original draft preparation, writing – review & editing. F Lacarrubba: data curation, formal analysis, investigation, visualization, writing-original draft preparation, writing – review & editing. L Genco: data curation, formal analysis, investigation, visualization, writing-original draft preparation, writing – review & editing. A Ruggiero: data curation, formal analysis, investigation, visualization, writing-original draft preparation, writing – review & editing. L Fornaro: data curation, formal analysis, investigation, visualization, writing-original draft preparation, writing – review & editing. G Guerrasio: data curation, formal analysis, investigation, visualization, writing-original draft preparation, writing – review & editing. L Potestio: data curation, formal analysis, investigation, visualization, writing-original draft preparation, writing – review & editing. All authors read and approved the final version of the manuscript.

Data availability statement

The data that support the findings of this study are available from the corresponding author, LP, upon reasonable request.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.