Postauthorization Safety Study (NISSO) Assessing the Long-Term Safety Profile of Sonidegib in Patients With Locally Advanced Basal Cell Carcinoma: Interim Analysis From the Spanish Cohort

Most patients experienced grade≤2 common TEAEs, such as muscle spasms, dysgeusia, and alopecia that mostly manifested 3 months into therapy. These interim results confirm the safety profile observed in the BOLT study, demonstrating that sonidegib is well-tolerated in a real-world setting in Spain.

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Publication Details

Journal
Actas Dermo-Sifiliográficas
Published
2025-12-04
DOI
https://doi.org/10.1016/j.ad.2025.104524
Primary Topic
Nonmelanoma Skin Cancer Studies
Type
article
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article

Postauthorization Safety Study (NISSO) Assessing the Long-Term Safety Profile of Sonidegib in Patients With Locally Advanced Basal Cell Carcinoma: Interim Analysis From the Spanish Cohort

M.J. Fuente, V. Ruiz-Salas, Ángeles Flórez, Gabriela Pastor et al.
Actas Dermo-Sifiliográficas
Nonmelanoma Skin Cancer Studies
article

Postauthorization Safety Study (NISSO) Assessing the Long-Term Safety Profile of Sonidegib in Patients With Locally Advanced Basal Cell Carcinoma: Interim Analysis From the Spanish Cohort

M.J. Fuente, V. Ruiz-Salas, Ángeles Flórez, Gabriela Pastor, Matías Mayor Arenal, Josep Malvehy, Renate M. Arntz, Patricia Bassas-Freixas, Ricardo Fernández‐de‐Misa, Rafael Botella Estrada, Perla Almazan, S. Bèa Ardébol
article en

Abstract

Most patients experienced grade≤2 common TEAEs, such as muscle spasms, dysgeusia, and alopecia that mostly manifested 3 months into therapy. These interim results confirm the safety profile observed in the BOLT study, demonstrating that sonidegib is well-tolerated in a real-world setting in Spain.

Actas Dermo-SifiliográficasVol. 117(2)
Hospital Universitario La Paz (ES), Hospital de Sant Pau (ES), Hospital Universitari i Politècnic La Fe (ES), Hospital Universitario Nuestra Señora de Candelaria (ES), Hospital Universitario de Gran Canaria Doctor Negrín (ES), Hospital Clínic de Barcelona (ES), Vall d'Hebron Hospital Universitari (ES), Hospital General Universitario De Valencia (ES), Hospital Universitari Germans Trias i Pujol (ES), Complejo Hospitalario de Pontevedra (ES), Hospital Universitario Ramón y Cajal (ES)
Openalex Percentile: Top 50%
Nonmelanoma Skin Cancer Studies
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Postauthorization Safety Study (NISSO) Assessing the Long-Term Safety Profile of Sonidegib in Patients With Locally Advanced Basal Cell Carcinoma: Interim Analysis From the Spanish Cohort — M.J. Fuente, V. Ruiz-Salas, et al. · Actas Dermo-Sifiliográficas (2025) | TGRS Research Map | TGRS