Drug updated on 9/4/2024
Dosage Form | Capsule (oral; 200 mg) |
Drug Class | Hedgehog pathway inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
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Summary
- Odomzo (sonidegib) is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Basal Cell Carcinoma (BCC) ORRs: Sonidegib demonstrated an ORR of 50.1%, while vismodegib exhibited a higher ORR of 68.5%.
- Medulloblastoma (MB) ORRs: Sonidegib achieved an ORR of 55% in SHH-driven MB, significantly outperforming vismodegib, which showed no efficacy in non-SHH MB, with sonidegib’s efficacy being 1.87-fold higher (95% CI 1.23, 6.69). This effect was more pronounced in pediatric patients, where sonidegib’s efficacy was 3.67-fold higher than vismodegib (p < 0.05).
- Common Adverse Effects in Basal Cell Carcinoma (BCC): Muscle spasms were reported in 61.0% of patients taking sonidegib and 70.5% for those on vismodegib; dysgeusia occurred in 48.6% (sonidegib) and 58.4% (vismodegib); alopecia was observed in 51.1% (sonidegib) and 59.9% (vismodegib).
- Specific Adverse Effects: Sonidegib was associated with higher incidences of nausea, diarrhea, increased creatine kinase levels, and decreased appetite, whereas vismodegib had a significantly higher incidence of weight loss (35.1%, p < 0.0001).
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Odomzo (sonidegib) Prescribing Information. | 2023 | Sun Pharmaceutical Industries, Inc., Cranbury, NJ |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Efficacy and safety of sonic hedgehog inhibitors in basal cell carcinomas: an updated systematic review and meta-analysis (2009-2022). | 2023 | American Journal of Clinical Dermatology |
Phase I and phase II sonidegib and vismodegib clinical trials for the treatment of paediatric and adult MB patients: a systemic review and meta-analysis. | 2019 | Acta Neuropathologica Communications |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Diagnosis and treatment of basal cell carcinoma: European consensus-based interdisciplinary guidelines. | 2019 | European Journal of Cancer |