Gazyvaro
Oncologyยท 594 cited findingsยท 2 source documents
Company: Roche Holding AG
What the regulatory reviews say
Gazyvaro is indicated for the treatment of adult patients with active lupus nephritis who are receiving standard therapy, and in combination with bendamustine followed by Gazyvaro maintenance for patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen. It received an orphan medicinal product designation for the treatment of chronic lymphocytic leukaemia on 10 October 2012, and a positive opinion for Marketing Authorisation on 22 May 2014. A Type II variation was submitted on 07 January 2025.
In efficacy studies, Gazyvaro demonstrated a B-cell depletion rate (CD19+ B-cell counts < 0.07 x 10^9/L) at end of treatment of 91%. The median progression-free survival (PFS) for UNFIT patients treated with Gazyvaro (GClb) was 27.7 months, compared to 16.9 months for UNFIT patients treated with RClb, with a PFS Hazard Ratio (95% CI) of 0.33. The overall survival stratified hazard ratio (95% CI) was 0.41.
Safety findings include an incidence of HAHA-positive patients at 12 months follow-up of 6%. The duration of contraception and breastfeeding cessation after treatment with obinutuzumab is 18 months. The median Cmax (Cycle 6 Day 1 infusion) in CLL patients was 473.2 ฮผg/mL.
Key figures โ cited to the source page
| B-cell depletion rate (CD19+ B-cell counts < 0.07 x 10^9/L) at end of treatment (BO21004/CLL11) | 91 % | Roche Holding AG โ Gazyvaro EMA EPAR public assessment repor, p.44 |
| Median PFS (months) for UNFIT patients (GClb) | 27.7 | Roche Holding AG โ Gazyvaro EMA EPAR public assessment repor, p.81 |
| Median PFS (months) for UNFIT patients (RClb) | 16.9 | Roche Holding AG โ Gazyvaro EMA EPAR public assessment repor, p.81 |
| PFS HR (95% CI) for UNFIT patients (GClb vs RClb) | 0.33 | Roche Holding AG โ Gazyvaro EMA EPAR public assessment repor, p.81 |
| OS stratified hazard ratio (95% CI) | 0.41 | Roche Holding AG โ Gazyvaro EMA EPAR public assessment repor, p.87 |
| Incidence of HAHA-positive patients at 12 months follow-up (BO21004/CLL11) | 6 % | Roche Holding AG โ Gazyvaro EMA EPAR public assessment repor, p.44 |
| Duration of contraception after treatment with obinutuzumab | 18 months | Roche Holding AG โ Gazyvaro EMA EPAR public assessment repor, p.39 |
| Orphan medicinal product designation date | 10 October 2012 | Roche Holding AG โ Gazyvaro EMA EPAR public assessment repor, p.7 |
Source documents
Explore the full evidence
All 594 cited findings for Gazyvaro 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.