Expert opinion on sonidegib efficacy, safety and tolerability

Expert Opin Drug Saf. 2021 Aug;20(8):877-882. doi: 10.1080/14740338.2021.1921734. Epub 2021 May 12.

Abstract

Introduction: Hedgehog inhibitors are an alternative treatment option for patients with advanced BCCs not eligible for standard therapies due to lack of efficacy, high recurrence risk, and high-rate morbidity. Sonidegib, an oral smoothened antagonist, has been approved for the treatment of adult patients with locally advanced basal cell carcinoma. Several studies and randomized controlled trials have been conducted in order to evaluate the efficacy, safety, and tolerability of this new molecule.Areas covered: The aim of this article is to provide a complete overview on the use of sonidegib for the treatment of advanced BCCs describing the efficacy, safety, and drug tolerability of this drug.Expert opinion: Sonidegib, with a different pharmacokinetics profile from that of the other SMO-inhibitor vismodegib, demonstrated to be an efficacious and well-tolerated treatment in patients with locally advanced BCC. Although several drug-related adverse events have already been described, different strategies should be taken into account to better manage this small molecule while avoiding treatment discontinuation. The use of sonidegib as neoadjuvant therapy or combined with other hedgehog pathway inhibitors targeting different sites and to date, only available for pre-clinical studies, should also be considered.

Keywords: Basal cell carcinoma; hedgehog pathway; skin cancer; sonidegib.

Publication types

  • Comparative Study
  • Review

MeSH terms

  • Anilides / administration & dosage
  • Anilides / adverse effects
  • Anilides / pharmacokinetics
  • Animals
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / pharmacokinetics
  • Biphenyl Compounds / administration & dosage*
  • Biphenyl Compounds / adverse effects
  • Biphenyl Compounds / pharmacokinetics
  • Carcinoma, Basal Cell / drug therapy*
  • Carcinoma, Basal Cell / pathology
  • Hedgehog Proteins / antagonists & inhibitors
  • Humans
  • Pyridines / administration & dosage*
  • Pyridines / adverse effects
  • Pyridines / pharmacokinetics
  • Randomized Controlled Trials as Topic
  • Skin Neoplasms / drug therapy*
  • Skin Neoplasms / pathology
  • Smoothened Receptor / antagonists & inhibitors

Substances

  • Anilides
  • Antineoplastic Agents
  • Biphenyl Compounds
  • Hedgehog Proteins
  • HhAntag691
  • Pyridines
  • SMO protein, human
  • Smoothened Receptor
  • sonidegib