Regulatory Decision Summary for Lanvis
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 was to update the Lanvis Product Monograph with safety and pharmacokinetic information and to remove the following approved indication: "Lanvis has also been used in chronic granulocytic (myolocytic, myeloid, myelogenous) leukemia" based on the current clinical practice.
Why was the decision issued?
Based on a review of the current clinical treatment paradigms for Chronic myeloid leukaemia (CML) the indication for CML has been removed.
The safety profile of Lanvis is considered sufficiently demonstrated with over four decades of use in patients with leukemia. Based on this SNDS review, the Lanvis Product Monograph was updated to include additional safety information including potentially serious infections from attenuated live vaccines if concomitantly used, baseline tests of thiopurine methyltransferase (TPMT) genotype or phenotype and reduced starting dose for those with TPMT deficiency, gastrointestinal perforations and necrotizing colitis, risk of skin cancer due to photosensitivity, and uncertainty regarding drug-drug interactions between Lanvis and allopurinol.
For the remaining indication of acute leukaemia, the potential benefits of Lanvis in combination therapy continue to outweigh the potential risks, and the benefit/risk profile remains favorable.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.