Drug updated on 9/4/2024
| 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.
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Summary
- Erivedge (vismodegib) 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 who are not candidates for surgery and who are not candidates for radiation.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Basal Cell Carcinoma (BCC): The pooled Overall Response Rate (ORR) for patients treated with sonic hedgehog inhibitors (SSHis) was 64.9% (95% CI 48.2-81.6%), with Vismodegib achieving an ORR of 68.5% and Sonidegib 50.1%.
- Medulloblastoma (MB): For relapsed SHH-driven MB, the pooled ORR was 37%, with Sonidegib showing an ORR of 55% and Vismodegib showing no efficacy in non-SHH MB. Sonidegib demonstrated 1.87-fold higher ORR than Vismodegib in SHH-driven MB (95% CI 1.23, 6.69), and 3.67-fold higher efficacy in pediatric patients (p < 0.05).
- In Basal Cell Carcinoma (BCC) patients, common adverse effects for vismodegib included muscle spasms (70.5%), dysgeusia (58.4%), alopecia (59.9%), and significant weight loss (35.1%, p < 0.0001). Sonidegib was associated with muscle spasms (61.0%), dysgeusia (48.6%), alopecia (51.1%), and higher incidences of nausea, diarrhea, increased creatine kinase levels, and decreased appetite compared to vismodegib.
- In Medulloblastoma (MB) patients, grade 3/4 dose-limiting toxicity (DLT) was reported in 36 out of 320 cases, with vismodegib showing an 11.6% rate of grade 3/4 DLT and sonidegib showing an 11.2% rate.
- There is no population types or subgroups information available in the reviewed studies.
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 |