Drug updated on 4/15/2024
| Dosage Form | Capsule (oral; 150 mg) |
| Drug Class | Hedgehog pathway inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation.
Summary
- Vismodegib (Erivedge) is indicated for the treatment of adults with metastatic basal cell carcinoma or with locally advanced basal cell carcinoma that has recurred following surgery, or for those who are not candidates for surgery and radiation. It demonstrated a pooled overall response rate of 68.5% in treating advanced basal cell carcinoma.
- The information was derived from two systematic reviews/meta-analyses focusing on Sonic Hedgehog inhibitors, specifically vismodegib (Erivedge) and sonidegib.
- In terms of the safety profile, adverse effects reported include muscle spasms (70.5%), dysgeusia (58.4%), alopecia (59.9%), and weight loss (35.1%). Weight loss was notably significant among these side effects.
- Compared to another drug called sonidegib used in similar conditions, vismodegib showed higher efficacy in treating advanced basal cell carcinoma but was less effective compared to sonidegib in SHH-driven medulloblastoma, especially among pediatric patients where sonidegib's efficacy was 3.67-fold higher.
- The use of both drugs in the treatment of advanced BCC in adults shows varying degrees of effectiveness; however, vismodegib generally proved more effective based on overall response rates.
- Considering population types and subgroup considerations such as age group-specific cancer subtype like SHH-driven MB, which predominantly affects children but also occurs in adults, sonidegib has shown superior effectiveness over vismodegib particularly amongst pediatric patients while maintaining comparable safety profiles across indications, albeit specific prevalence varied between adverse effects.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Erivedge (vismodegib) Prescribing Information. | 2023 | Genentech USA, Inc., South San Francisco, CA |
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 |
|---|---|---|
| Japanese dermatological association guidelines: outlines of Japanese clinical guidelines for basal cell carcinoma 2021. | 2024 | The Journal of dermatology |
| European consensus-based interdisciplinary guideline for diagnosis and treatment of basal cell carcinoma-update 2023 | 2023 | European Journal of Cancer |
| Vismodegib for basal cell carcinoma and beyond: what dermatologists need to know. | 2022 | Cutis |
| Diagnosis and treatment of basal cell carcinoma: European consensus–based interdisciplinary guidelines. | 2019 | European Journal of Cancer |
| A practical guide for the follow-up of patients with advanced basal cell carcinoma during treatment with hedgehog pathway inhibitors. | 2019 | The Oncologist |