Sonidegib: Safety and Efficacy in Treatment of Advanced Basal Cell Carcinoma

Abstract

Hedgehog inhibitors are promising alternative treatments for patients with advanced basal cell carcinomas. Sonidegib (Odomzo Ò ), 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 repor-ted. 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.

Complete remission of an advanced basal cell carcinoma after only 3‐month treatment with sonidegib: Report of a case and drug management during COVID ‐19 pandemic

“…Sonidegib is a novel molecule that acts by inhibiting smoothened (SMO) protein, thus blocking the hedgehog pathway and tumor cells transcriprion. It was approved in July 2015 by the Food and Drugs Administration (FDA) and is available in 200 mg capsules for patients aged >18 years with laBCC who present recurrence to other treatments or who are not candidates for surgery or radiotherapy 5 . This is the first case reported in literature regarding the efficacy of sonidegib and the importance of teledermatology as a useful tool for drug management during the COVID‐19 pandemic period 6,7 .…”

Clinical Management of Locally Advanced Basal-Cell Carcinomas and Future Therapeutic Directions

“…Both drugs have a similar mechanism of action: thus, upon resistance, it is usually not beneficial to use one in place of the other. Another major drawback of both agents is a characteristic adverse event profile including dysgeusia, muscle spasms, weight loss, asthenia and alopecia, affecting the majority of patients [19]. Side effects are usually not life threatening, but therapy limiting in up to a third of cases as they greatly affect quality of life.…”

Management of locally advanced basal cell carcinoma treated with sonidegib: The experience of an Italian reference hospital

“…The coronavirus disease (COVID‐19) outbreak caused by an infection with severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) poses several challenges to treatment decisions and management of oncologic patients with advanced skin cancers 1 . Sonidegib, an orally dosed smoothened (SMO) antagonist, is approved for the treatment of adult patients with locally advanced basal cell carcinomas (laBCCs) that are not candidates for surgery or radiotherapy 2‐4 …”

“…ment of adult patients with locally advanced basal cell carcinomas (laBCCs) that are not candidates for surgery or radiotherapy. [2][3][4] Herein we present a case of an 80-year-old woman with laBCCs the patient was already very satisfied with the treatment efficacy, and she requested to be put on the approved every other day dose.…”