Last Updated : April 22, 2024
Details
FilesGeneric 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
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:
- 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.
| Call for patient/clinician input open | June 06, 2023 |
|---|---|
| Call for patient/clinician input closed | July 28, 2023 |
| Clarification: - Patient input submission received from Lymphoma Canada | |
| Submission received | July 18, 2023 |
| Submission accepted | August 01, 2023 |
| Review initiated | August 02, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | October 19, 2023 |
| Deadline for sponsors comments | October 30, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | November 24, 2023 |
| Expert committee meeting (initial) | December 06, 2023 |
| Draft recommendation issued to sponsor | December 20, 2023 |
| Draft recommendation posted for stakeholder feedback | January 04, 2024 |
| End of feedback period | January 18, 2024 |
| Final recommendation issued to sponsor and drug plans | February 02, 2024 |
| Final recommendation posted | February 21, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | February 16, 2024 |
| CADTH review report(s) posted | April 22, 2024 |
Files
Last Updated : April 22, 2024