Regulatory Decision Summary for Columvi
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 seek a marketing authorization with conditions for Columvi (glofitamab) for use in the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified (DLBCL-NOS), DLBCL arising from follicular lymphoma (trFL), high grade B-cell lymphoma (HGBCL), and primary mediastinal B-cell lymphoma (PMBCL), who cannot receive CAR-T cell therapy, or have previously received CAR-T cell therapy.
After evaluation, Health Canada authorized, with conditions, Columvi for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL) not otherwise specified, DLBCL arising from follicular lymphoma (trFL), or primary mediastinal B-cell lymphoma (PMBCL), who have received two or more lines of systemic therapy and are ineligible for or cannot receive CAR-T therapy or have received previous CAR-T cell therapy.
Why was the decision issued?
Authorization was based on one Phase I/II, international, multi-centre, multi-cohort, single-arm, trial, NP30179. Patients (n = 108) with relapsed or refractory diffuse large B-cell lymphoma who had received 2 or more prior lines of systemic therapy received obinutuzumab pre-treatment followed by up to 12 cycles of glofitamab. Each cycle is 21 days in length.
The primary efficacy endpoint was the complete response rate (CRR). In the 108 patients in the primary efficacy population, the CRR was 35.2%.
The most common adverse reactions (ADRs) reported in at least 20% of patients were cytokine release syndrome, neutropenia, anemia, and thrombocytopenia.
Based on the evidence of efficacy and safety from NP30179, the benefit of treatment outweighs the risk when the product is used according to the product monograph (PM).
The recommended dose of the drug is 2.5 mg on Day 8, 10 mg on day 15 and 30 mg on Day 1 of each cycle beginning at cycle 2. Dosing is preceded by 1,000 mg obinutuzumab, administered on Day 1 of the first cycle. Each cycle is 21 days in length. View the PM for complete details.
Health Canada granted this application advanced consideration under the NOC/c policy.
Decision issued
Authorized; issued a Notice of Compliance (NOC) in accordance with the Food and Drug Regulations, as per the Notice of Compliance with Conditions Guidance.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| COLUMVI | 02536560 | HOFFMANN-LA ROCHE LIMITED | GLOFITAMAB 10 MG / 10 ML |
| COLUMVI | 02536552 | HOFFMANN-LA ROCHE LIMITED | GLOFITAMAB 2.5 MG / 2.5 ML |