lisocabtagene maraleucel

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Generic Name:
lisocabtagene maraleucel
Project Status:
Complete
Therapeutic Area:
Relapsed or refractory large B-cell lymphoma
Manufacturer:
Celgene Inc., a Bristol Myers Squibb company (Celgene)
Brand Name:
Breyanzi
Project Line:
Reimbursement Review
Project Number:
PG0258-000
Tumour Type:
Lymphoma
NOC Status at Filing:
Pre NOC
Performance Metric:
N/A delay outside our control - Temporary suspension and/or submission of new information by sponsor
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, 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.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule E
Tumour Type:
Lymphoma
Indications:
​For the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, 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.lymphoma, primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B) after at least 2 prior therapies.
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 open09-Jul-21
Call for patient/clinician input closed03-Sep-21
Clarification:

- Patient input submission received from Lymphoma Canada

Submission received09-Aug-21
Submission accepted23-Aug-21
Clarification:

- Submission temporarily suspended

- Additional information has been received and the temporary suspension of the review has been lifted

Review initiated24-Aug-21
Draft CADTH review report(s) provided to sponsor for comment16-Dec-21
Clarification:

- Submission temporarily suspended

Deadline for sponsors comments18-Jan-22
CADTH review report(s) and responses to comments provided to sponsor01-Apr-22
Expert committee meeting (initial)13-Apr-22
Draft recommendation issued to sponsor24-May-22
Draft recommendation posted for stakeholder feedback02-Jun-22
End of feedback period16-Jun-22
Final recommendation issued to sponsor and drug plans29-Jun-22
Final recommendation posted18-Jul-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)14-Jul-22
CADTH review report(s) posted03-Oct-22