Regulatory Decision Summary for Epkinly
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.
Type of Submission:
New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Authorized; issued a Notice of Compliance in accordance with the Food and Drug Regulations, as per the Notice of Compliance with Conditions Guidance
What was the purpose of this submission?
The purpose of this submission was to seek marketing authorization with conditions for Epkinly (epcoritamab) for the use in the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, where patient is unable to receive or has previously received CAR-T cell therapy.
After evaluation, Health Canada authorized, with conditions, Epkinly for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, DLBCL transformed from indolent lymphoma, high grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL) or follicular lymphoma Grade 3B (FLG3b) after two or more lines of systemic therapy and who have previously received or are unable to receive CAR-T cell therapy.
Why was the decision issued?
Marketing authorization for Epkinly was based on the results of one Phase I/II, international single arm trial, EPCORE NHL-1. A total of 157 patients with aggressive large B-cell lymphomas who had received two or more prior lines of systemic therapy were treated with Epkinly, a bispecific antibody targeting CD20 on B-cells and CD3 on T cells, that induces T-cell activation and T-cell mediated killing of CD20 expressing B-cell lymphomas. Patients were treated with lower priming and intermediate doses of Epkinly over the first two weeks of treatment to manage adverse reactions before a full dose of Epkinly was given to patients who were treated until disease progression, unacceptable toxicity or death.
The primary efficacy endpoint on study was overall response rate (ORR) with complete response (CR) rate as a key secondary endpoint. In the 157 patients, the ORR was 63% with 39% of all patients achieving a CR. The median duration of complete response (DOCR) was 12 months.
Key safety concerns for Epkinly include cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), cytopenias and infections. The information in the product monograph describes these events including how to manage them based on severity along with a Serious Warnings and Precautions box for CRS and ICANS.
The overall benefit-risk profile of Epkinly is considered favourable when the product is used in accordance with instructions provided in the Product Monograph.
For further details about Epkinly, please refer to the Product Monograph approved by Health Canada and available through the Drug Product Database.
Health Canada granted this application advanced consideration under the NOC/c policy.
Date of Decision:
Manufacturer / Sponsor:
Drug Identification Number(s) Issued:
Schedule D drug