Roche Holding AG — Gazyvaro EMA EPAR variation assessment report (EMEA/H/C/002799, 2014)
Roche Holding AG · 2014 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes Roche's Type II variation application for Gazyvaro (obinutuzumab) to treat active lupus nephritis, based on the Phase III REGENCY and supportive Phase II NOBILITY studies. The REGENCY trial demonstrated a statistically significant improvement in complete renal response at Week 76 with obinutuzumab compared to placebo. Pharmacokinetic analyses detailed obinutuzumab's exposure and covariate influences, while pharmacodynamic studies showed a positive exposure-response relationship for efficacy and a weak correlation with neutropenia. The safety profile, consistent with previous observations, highlighted infusion-related reactions, infections, and neutropenia, with decreased blood IgM noted as a new adverse reaction in lupus nephritis patients. The application also addresses the withdrawal of Gazyvaro's orphan designation for follicular lymphoma due to this new non-orphan indication.
Key findings — cited to the page
| p-value for relationship between exposure and any grade neutropenia | 0.015 | · p.43 |
| p-value for relationship between exposure and Grade 3 and above neutropenia | 0.056 | · p.43 |
| Grade 3-4 AEs (obinutuzumab pool) | 29.0 % | · p.133 |
| IRRs in placebo arm | 10.4 % | · p.124 |
| Grade 3-4 neutropenia in obinutuzumab arm | 7 % | · p.126 |
| Grade 3-4 neutropenia in placebo arm | 0.5 % | · p.126 |
| Grade 3-4 adverse events (obinutuzumab arm) | 29.0 % | · p.120 |
| Grade 3-4 IRRs in obinutuzumab arm | 1.5 % | · p.124 |
| Grade 3-4 adverse events (placebo arm) | 18.1 % | · p.120 |
| IRRs in obinutuzumab arm | 13.5 % | · p.124 |
| Grade 3-4 IRRs in placebo arm | 0.5 % | · p.124 |
| Grade 3-4 AEs (placebo pool) | 18.1 % | · p.133 |
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 →