Roche Holding AG — Gazyvaro EMA EPAR public assessment report (EMEA/H/C/002799, 2014)
Roche Holding AG · 2014 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's assessment of Roche's Gazyvaro (obinutuzumab) for chronic lymphocytic leukaemia (CLL) resulted in a positive marketing authorization opinion in May 2014. Indicated for previously untreated adult CLL patients unsuitable for full-dose fludarabine, Gazyvaro is administered with chlorambucil. The report details Gazyvaro's quality, manufacturing, and non-clinical pharmacology, highlighting its enhanced direct cell death and B-cell depletion compared to rituximab due to glycoengineering. Preclinical studies confirmed superior ADCC potency and B-cell depletion, with pharmacokinetic and toxicity data in animal models. Pivotal Phase III study BO21004/CLL11 demonstrated Gazyvaro plus chlorambucil (GClb) significantly improved progression-free survival and overall response rates compared to rituximab plus chlorambucil (RClb) and chlorambucil alone. While GClb showed more adverse events (infusion-related reactions, neutropenia, thrombocytopenia), it led to fewer deaths. The CHMP deemed the benefit-risk balance favorable, recommending authorization with post-marketing commitments for overall survival data.
Key findings — cited to the page
| CTC Grade 4 neutropenia (BO20999) | 5 | BO20999 · p.46 |
| NCICTC Grade 3 neutropenia (BO20999) | 4 | BO20999 · p.46 |
| proportion of patients experiencing Grade 3-4 IRRs (before amendments) | 13.9% | · p.107 |
| incidence of serious IRRs (before amendment) | 8.3% | · p.107 |
| proportion of patients experiencing IRRs leading to treatment discontinuation (after amendments) | 7.1% | · p.107 |
| proportion of patients experiencing IRRs leading to treatment discontinuation (before amendments) | 5.6% | · p.107 |
| overall incidence of all grade IRRs (before amendment) | 61.1% | · p.107 |
| overall incidence of all grade IRRs | 52.9% | · p.107 |
| proportion of patients experiencing Grade 3-4 IRRs (after amendments) | 17.1% | · p.107 |
| incidence of serious IRRs (after amendment) | 6.4% | · p.107 |
| AUC (tau) higher in DLBCL vs CLL patients | 39 % | · p.45 |
| Median PFS (months) for UNFIT patients (RClb) | 16.9 | Study BO21004/CLL11 Stage 2 · p.81 |
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 →