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

polatuzumab vedotin

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Generic 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.
  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 open17-Oct-24
Call for patient/clinician input closed06-Dec-24
Submission received27-Nov-24
Submission accepted11-Dec-24
Review initiated12-Dec-24
Draft CADTH review report(s) provided to sponsor for comment09-Apr-25
Deadline for sponsors comments15-Apr-25
CADTH review report(s) and responses to comments provided to sponsor02-May-25
Expert committee meeting (initial)14-May-25
Draft recommendation issued to sponsorMay 27, 2025
To
May 29, 2025
Draft recommendation posted for stakeholder feedback05-Jun-25
End of feedback period19-Jun-25

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Patient and Clinician Group Input View PDF
Last Updated : March 5, 2025