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

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.