Regulatory Decision Summary for Gazyva

This Supplement to a New Drug Submission (SNDS) was filed for Gazyva (obinutuzumab) to seek authorization of a new indication for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy. Upon review of the submitted data package, Health Canada authorized Gazyva as filed.

The submission was reviewed using the international review work-sharing model with the Access Consortium. The Australian Therapeutic Goods Administration reviewed the clinical modules. Health Canada and Swissmedic participated as peer reviewers.

The sponsor consented to information sharing between Health Canada and health technology assessment organizations as part of an aligned review pathway.

Lupus nephritis is a serious and progressive disease with few treatment options available to slow or reverse kidney damage. This submission included a Phase 3 study conducted in adult patients with Class III or IV lupus nephritis (LN), with or without concomitant Class V disease, treated with Gazyva or placebo in addition to standard of care (glucocorticoid plus calcineurin inhibitor). Patients treated with Gazyva demonstrated a significant improvement over those treated with placebo at Week 76 for the endpoints of complete renal response (CRR), CRR with successful prednisone taper, and proteinuric response. The safety profile for Gazyva in LN patients was consistent with the established profile for the use of Gazyva in oncologic indications. The most common adverse events were infusion-related reactions (IRRs), infections, and neutropenia. There were limited long-term data available beyond 76 weeks.

An updated Risk Management Plan (RMP) for Gazyva was reviewed by Health Canada and considered acceptable. The RMP identified appropriate monitoring (pharmacovigilance) activities and risk minimization measures for Gazyva. This includes providing information in the product monograph and identifying populations and areas where more data are needed. Results related to the safety and effectiveness of Gazyva from ongoing and planned studies will be submitted in Periodic Safety Update Reports (PSURs) as they become available.

Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.

Overall, the benefit-risk profile for Gazyva was favourable for the approved indication when used under the conditions of use recommended in the approved Product Monograph. Therefore, a Notice of Compliance (NOC) was recommended.

For further details about Gazyva, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.