glofitamab

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Generic Name:
glofitamab
Project Status:
Complete
Therapeutic Area:
Relapsed or refractory diffuse large B-cell lymphoma
Manufacturer:
Hoffmann-La Roche Limited
Call for patient/clinician input open:
Brand Name:
Columvi
Project Line:
Reimbursement Review
Project Number:
PC0320-000
Call for patient/clinician input closed:
Tumour Type:
Lymphoma
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Glofitamab is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (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 to receive or cannot receive CAR-T cell therapy or have previously received CAR-T cell therapy, following obinutuzumab pre-treatment.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​Glofitamab is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (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 to receive or cannot receive CAR-T cell therapy or have previously received CAR-T cell therapy.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input openJune 06, 2023
Call for patient/clinician input closedJuly 28, 2023
Clarification:

- Patient input submission received from Lymphoma Canada

Submission receivedJuly 18, 2023
Submission acceptedAugust 01, 2023
Review initiatedAugust 02, 2023
Draft CADTH review report(s) provided to sponsor for commentOctober 19, 2023
Deadline for sponsors commentsOctober 30, 2023
CADTH review report(s) and responses to comments provided to sponsorNovember 24, 2023
Expert committee meeting (initial)December 06, 2023
Draft recommendation issued to sponsorDecember 20, 2023
Draft recommendation posted for stakeholder feedbackJanuary 04, 2024
End of feedback periodJanuary 18, 2024
Final recommendation issued to sponsor and drug plansFebruary 02, 2024
Final recommendation postedFebruary 21, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)February 16, 2024
CADTH review report(s) postedApril 22, 2024