Regulatory Decision Summary for Gazyva
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
The purpose of this submission is to request an indication extension for Gazyva in combination with bendamustine followed by Gazyva maintenance in patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab containing regimen.
Why was the decision issued?
Advanced follicular lymphoma (FL) remains incurable and treatment options are limited for patients who relapsed after, or are refractory to rituximab containing therapies.
Gazyva in combination with bendamustine for 6 cycles followed by Gazyva monotherapy for up to two years demonstrated a clinically meaningful and statistically significant improvement in median progression-free survival (PFS) compared to bendamustine alone for 6 cycles in patients with follicular lymphoma who relapsed after, or were refractory to, a rituximab containing regimen (14.9 months vs, not reached, HR 0.55, 95% CI: 0.40-0.74; p-value < 0.0001). The safety profile of Gazyva in combination with bendamustine followed by Gazyva monotherapy in patients with indolent Non-Hodgkins lymphoma (81% patients with follicle lymphoma) is in general consistent with the known risk of Gazyva therapy.
With demonstrated clinically meaningful and statistically significant improvement in the median PFS, the safety profile of Gazyva in combination with bendamustine followed by Gazyva monotherapy is considered acceptable in a patient population with an incurable advanced disease and limited treatment options. Updated safety information including risk of GI perforation has been adequately captured in the Product Monograph of Gazyva. An appropriate pharmacovigilance plan including upgrading the risk of GI perforation from a potential risk to an identified risk, is updated in the Risk Management Plan (RMP) for Gazyva.
Overall, the benefit/risk profile is considered favorable for Gazyva in combination with bendamustine followed by Gazyva monotherapy for treatment of patients with follicular lymphoma who relapsed after, or are refractory to, a rituximab containing therapy.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations