Canada’s Drug Agency | Drugs, Health Technologies and Systems.

glofitamab

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Generic Name:
glofitamab
Project Status:
Active
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:
PC0406-000
Call for patient/clinician input closed:
Tumour Type:
Lymphoma
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Columvi (glofitamab for injection) in combination with gemcitabine and oxaliplatin for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are not candidates for autologous stem cell transplant (ASCT).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​Columvi (glofitamab for injection) in combination with gemcitabine and oxaliplatin for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are not candidates for autologous stem cell transplant (ASCT).
  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 open29-Jan-25
Call for patient/clinician input closed24-Mar-25
Submission received07-Mar-25
Submission accepted24-Mar-25
Review initiated25-Mar-25
Draft CADTH review report(s) provided to sponsor for comment17-Jun-25
Deadline for sponsors comments26-Jun-25
CDA-AMC review report(s) and responses to comments provided to sponsor31-Jul-25
Expert committee meeting (initial)13-Aug-25
Draft recommendation issued to sponsorAugust 25, 2025
To
August 27, 2025
Draft recommendation posted for stakeholder feedback04-Sep-25
End of feedback period18-Sep-25

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Patient and Clinician Group Input View PDF
Last Updated : April 15, 2025