Erivedge
Oncologyยท 262 cited findingsยท 2 source documents
Company: Roche Holding AG
What the regulatory reviews say
Erivedge is indicated for the treatment of adult patients with symptomatic metastatic basal cell carcinoma (BCC) or locally advanced BCC unsuitable for surgery or radiation therapy. In a study of 104 patients, the median progression-free survival by investigator assessment was 9.2 months. The overall response rate by Independent Review Facility (IRF) assessment was 33.3% (95% CI: 19.2%, 51.8%). Complete responses were not observed.
Safety findings include mortality rates of 5.8% and 9.1%. Among patients assessed for reversibility of muscle spasms (N=266), 41% had ongoing treatment and 14% were lost to follow-up. The original exposure threshold for teratogenic risk was 0.0037 ฮผM. Regulatory milestones include a Marketing Authorisation application submission on 1 December 2011 and a positive opinion for conditional Marketing Authorisation on 25 April 2013.
Key figures โ cited to the source page
| Median progression-free survival by investigator assessment | 9.2 months | Roche Holding AG โ Erivedge EMA EPAR public assessment repor, p.54 |
| Overall response rate by IRF assessment | 33.3 % | Roche Holding AG โ Erivedge EMA EPAR public assessment repor, p.62 |
| Overall response rate by IRF assessment 95% CI | (19.2%, 51.8%) | Roche Holding AG โ Erivedge EMA EPAR public assessment repor, p.62 |
| Mortality rate | 5.8 % | Roche Holding AG โ Erivedge EMA EPAR variation assessment re, p.6 |
| Mortality rate | 9.1 % | Roche Holding AG โ Erivedge EMA EPAR variation assessment re, p.6 |
| Original exposure threshold for teratogenic risk | 0.0037 ฮผM | Roche Holding AG โ Erivedge EMA EPAR variation assessment re, p.8 |
| Marketing Authorisation application submission date | 1 December 2011 | Roche Holding AG โ Erivedge EMA EPAR public assessment repor, p.4 |
| Positive opinion for conditional Marketing Authorisation date | 25 April 2013 | Roche Holding AG โ Erivedge EMA EPAR public assessment repor, p.6 |
Source documents
Explore the full evidence
All 262 cited findings for Erivedge โ searchable, comparable and answerable in plain language โ are in the Oncology research library โ
Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials โ values are not head-to-head comparisons). Educational reference only โ not medical or investment advice.