Last Updated : January 21, 2025
Details
FilesGeneric Name:
polatuzumab vedotin
Project Status:
Active
Therapeutic Area:
Large B-cell lymphoma
Manufacturer:
N/A
Call for patient/clinician input open:
Brand Name:
Polivy
Project Line:
Reimbursement Review
Project Number:
PC0397-000
Call for patient/clinician input closed:
Tumour Type:
Lymphoma
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Polivy (polatuzumab vedotin for injection) in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adult patients with previously untreated large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), high grade B-cell lymphoma, Epstein-Barr virus-positive (EBV+) DLBCL NOS, and T-cell/histiocyte rich LBCL that are classified as activated B-cell-like (ABC) lymphoma subtype.
Submission Type:
Resubmission
Companion Diagnostics:
Yes
Fee Schedule:
N/A
Indications:
Polivy (polatuzumab vedotin for injection) in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adult patients with previously untreated large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), high grade B-cell lymphoma, Epstein-Barr virus-positive (EBV+) DLBCL NOS, and T-cell/histiocyte rich LBCL.
- 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.
| Call for patient/clinician input open | October 17, 2024 |
|---|---|
| Call for patient/clinician input closed | December 06, 2024 |
| Submission received | November 27, 2024 |
| Submission accepted | December 11, 2024 |
| Review initiated | December 12, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | March 13, 2025 |
| Deadline for sponsors comments | March 25, 2025 |
| CADTH review report(s) and responses to comments provided to sponsor | May 02, 2025 |
| Expert committee meeting (initial) | May 14, 2025 |
| Draft recommendation issued to sponsor | May 27, 2025 To May 29, 2025 |
| Draft recommendation posted for stakeholder feedback | June 05, 2025 |
| End of feedback period | June 19, 2025 |
Files
Last Updated : January 21, 2025