epcoritamab

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Generic Name:
epcoritamab
Project Status:
Active
Therapeutic Area:
Relapsed or refractory diffuse large B-cell lymphoma
Manufacturer:
AbbVie Corporation
Call for patient/clinician input open:
Brand Name:
Epkinly
Project Line:
Reimbursement Review
Project Number:
PC0334-000
Call for patient/clinician input closed:
Tumour Type:
Lymphoma
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS), 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.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS), 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.
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input openSeptember 29, 2023
Call for patient/clinician input closedNovember 27, 2023
Clarification:

- Patient input submission received from Lymphoma Canada and the Leukemia & Lymphoma Society of Canada

Submission receivedNovember 14, 2023
Clarification:

Eligible for consideration as a time-limited recommendation

Submission acceptedNovember 28, 2023
Review initiatedNovember 29, 2023
Draft CADTH review report(s) provided to sponsor for commentFebruary 23, 2024
Deadline for sponsors commentsMarch 05, 2024
CADTH review report(s) and responses to comments provided to sponsorMarch 28, 2024
Expert committee meeting (initial)April 10, 2024
Draft recommendation issued to sponsorApril 24, 2024
Draft recommendation posted for stakeholder feedbackMay 02, 2024
End of feedback periodMay 16, 2024
Final recommendation issued to sponsor and drug plansMay 31, 2024
Final recommendation posted-
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)June 14, 2024
CADTH review report(s) posted-