Last Updated : June 19, 2024
Details
FilesGeneric Name:
lisocabtagene maraleucel
Project Status:
Active
Therapeutic Area:
Relapsed or refractory large B-cell lymphoma
Manufacturer:
Bristol Myers Squibb Canada
Call for patient/clinician input open:
Brand Name:
Breyanzi
Project Line:
Reimbursement Review
Project Number:
PG0358-000
Call for patient/clinician input closed:
Tumour Type:
Lymphoma
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Breyanzi (lisocabtagene
maraleucel) is a CD19-directed genetically modified autologous T cell
immunotherapy indicated for the treatment of adult patients with large B-cell
lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise
specified, primary mediastinal large B-cell lymphoma (PMBCL), high grade B-cell
lymphoma, and DLBCL arising from follicular lymphoma, who are refractory or
have relapsed within 12 months of initial therapy and are candidates for
autologous haematopoietic stem cell transplant (HSCT).
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
Breyanzi (lisocabtagene
maraleucel) is a CD19-directed genetically modified autologous T cell
immunotherapy indicated for the treatment of adult patients with large B-cell
lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise
specified, primary mediastinal large B-cell lymphoma (PMBCL),
high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma, who are
refractory or have relapsed within 12 months of initial therapy and are
candidates for autologous haematopoietic stem cell transplant (HSCT).
- 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 | 26-Mar-24 |
|---|---|
| Call for patient/clinician input closed | 21-May-24 |
| Submission received | 08-May-24 |
| Submission accepted | 23-May-24 |
| Review initiated | 24-May-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 21-Aug-24 |
| Deadline for sponsors comments | 30-Aug-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 26-Sep-24 |
| Expert committee meeting (initial) | 09-Oct-24 |
| Draft recommendation issued to sponsor | October 22, 2024 To October 24, 2024 |
| Draft recommendation posted for stakeholder feedback | 31-Oct-24 |
| End of feedback period | 15-Nov-24 |
Files
Last Updated : June 19, 2024