Health Canada approves Minjuvi + lenalidomide for diffuse large B-cell lymphoma.
The conditional approval is based on data from the L-MIND study, an open label, multicentre single arm study evaluating the safety and efficacy of Minjuvi in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL who are not eligible for ASCT, and is supported by the RE-MIND study, an observational retrospective study in relapsed or refractory DLBCL. Removal of the conditions from the Notice of Compliance is contingent upon verification and description of clinical benefit in a confirmatory trial(s).
The results from L-MIND showed an overall response rate (ORR) of 53.5% (primary endpoint), including a complete response (CR) rate of 35.2% and a partial response rate (PR) of 18.3%, as assessed by an independent review committee. The median duration of response (mDOR) was 34.6 months (secondary endpoint). Adverse events (AEs) reported included infusion-related reactions, serious or severe myelosuppression, including neutropenia, thrombocytopenia, anemia, infections and tumour lysis syndrome.
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