Regulatory Decision Summary for Adcetris
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?
After evaluation of the submitted data package, Health Canada authorized Adcetris (brentuximab vedotin) for the following indication:
Adcetris is indicated for the treatment of previously untreated adult patients with systemic anaplastic large cell lymphoma (sALCL), peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma (AITL), whose tumours express CD30, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP).
Why was the decision issued?
Authorization was based on results of a multi-centre, randomized, double-blind, placebo-controlled, phase III trial (SGN35-014). The study enrolled patients with CD30 expression in ≥10% neoplastic cells and 98% of the randomized patients had either systemic anaplastic large-cell lymphoma (sALCL), peripheral T-cell lymphoma- not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma (AITL). Patients (N=452) received either Adcetris with cyclophosphamide, doxorubicin and prednisone (A+CHP) (n=226) or cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) (n=226) every 3 weeks for 6 or 8 cycles.
The result of the primary analysis of progression-free survival (PFS) indicated a reduction on the risk of death, disease progression or receipt of new therapy by 29% among Adcetris-treated subjects, with an improvement on median PFS of 17.4 months. The result of the analysis of overall survival (OS), the key secondary endpoint, indicated that the treatment of A+CHP provided a survival benefit as compared to CHOP with a reduction on the risk of death of 34%, which is considered clinically meaningful. The safety results from Study SGN35-014 were consistent with the established safety profile of Adcetris.
Health Canada granted this application priority review. A Notice of Compliance (NOC) was recommended based on a positive benefit-risk profile of Adcetris in combination with CHP for the treatment of patients with CD30-expressing sALCL, PTCL-NOS or AITL.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.