Roche Holding AG — Erivedge EMA EPAR public assessment report (EMEA/H/C/002602, 2013)
Roche Holding AG · 2013 · EMA EPAR public assessment report · company profile →
Report summary
This report summarizes the EMA's assessment of Erivedge (vismodegib), an oral Hedgehog pathway inhibitor, for advanced basal cell carcinoma. It details the product's quality, pharmacology, and non-clinical safety, including negative genotoxicity but concerns regarding tumorigenesis and severe embryotoxicity/teratogenicity. Pharmacokinetic analysis and the design of pivotal Phase I and II studies (SHH4476g, SHH3925g) are outlined. Efficacy, demonstrated in a Phase II trial (104 patients) for metastatic and locally advanced BCC, showed objective response rates and duration of response. The report also covers the Risk Management Plan, addressing identified risks like teratogenicity and muscle spasms, and post-marketing commitments. Erivedge received conditional marketing authorization due to unmet medical need.
Key findings — cited to the page
| grade >3 fatigue | 6 % | · p.92 |
| grade >3 weight decrease | 7 % | · p.92 |
| grade >3 muscle spasms | 3 % | · p.92 |
| grade >3 hyponatremia | 4 % | · p.92 |
| study phase | Ib | GP27839 · p.84 |
| enrollment N | 30 patients | GP27839 · p.87 |
| complete responses | 0 | · p.91 |
| median progression-free survival by investigator assessment | 11.3 months | · p.54 |
| overall response rate by IRF assessment | 33.3 % | · p.62 |
| median progression-free survival by investigator assessment | 9.2 months | · p.54 |
| number of patients enrolled | 104 | SHH4476g · United States, England, France, Germany, Belgium, Australia · p.47 |
| number of metastatic BCC patients | 33 | SHH4476g · p.47 |
Source: Roche Holding AG ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →