Roche Holding AG — Erivedge EMA EPAR variation assessment report (EMEA/H/C/002602, 2013)
Roche Holding AG · 2013 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the variation assessment for Roche Holding AG's Erivedge (vismodegib), focusing on updates to safety and efficacy data from the MO25616 (STEVIE) study. The assessment recommends a full marketing authorization, removing previous obligations. Key changes to product information include adjusting the waiting period for women of childbearing potential post-treatment and removing hyponatremia as an important potential risk. Pharmacovigilance activities address concerns like syncope, carcinogenicity, and teratogenicity. The report also details the removal of hyponatremia from adverse effects and the addition of increased blood creatine phosphokinase, alongside ongoing discussions regarding pregnancy prevention duration.
Key findings — cited to the page
| Patients with post-baseline grade 1 creatinine elevations not reverting to < ULN | 11.5 % | · p.6 |
| patients with grade 0 baseline creatinine without worsening in MO25616 | 66 % | MO25616 · p.41 |
| patients with grade 0 baseline creatinine without worsening in MO25616 | 318 of 479 | MO25616 · p.41 |
| patients with grade 0 baseline creatinine without worsening in MO25616 | 7.3 % | MO25616 · p.41 |
| patients shifted from grade 0 to grade 1 creatinine in MO25616 | 65 % | MO25616 · p.41 |
| patients shifted from grade 0 to grade 1 creatinine in MO25616 | 795 | MO25616 · p.41 |
| patients with grade 0 baseline creatinine without worsening in MO25616 | 87 | MO25616 · p.41 |
| Mortality rate | 9.1 % | MO25616 · p.6 |
| Mortality rate | 5.8 % | MO25616 · p.6 |
| Patients assessed for reversibility of muscle spasms | 266 | · p.6 |
| Procedure Number | EMEA/H/C/002602/II/0025/G | Erivedge · p.1 |
| Opinion date | 15 September 2016 | · p.2 |
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 →