tafasitamab


( Last Updated : May 25, 2022)
Generic Name:
tafasitamab
Project Status:
Active
Therapeutic Area:
Diffuse large B-cell lymphoma (DLBCL)
Manufacturer:
Incyte Biosciences Canada Corporation
Brand Name:
Minjuvi
Project Line:
Reimbursement Review
Project Number:
PC0266-000
Tumour Type:
Lymphoma
NOC Status at Filing:
Post NOC

Details

Manufacturer Requested Reimbursement Criteria1:
In combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, who are not eligible for autologous stem cell transplant (ASCT).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Tafasitamab is indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, who are not eligible for autologous stem cell transplant (ASCT).
  1. 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.

Key Milestones2

Call for patient/clinician input open15-Oct-21
Call for patient/clinician input closed09-Dec-21
Clarification:

- Patient input submission received from Lymphoma Canada

Submission received19-Nov-21
Submission accepted03-Dec-21
Review initiated06-Dec-21
Draft CADTH review report(s) provided to sponsor for comment25-Feb-22
Deadline for sponsors comments08-Mar-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 sponsor27-Apr-22
Draft recommendation posted for stakeholder feedback05-May-22
End of feedback period19-May-22
Clarification:

- Reconsideration: major revisions requested by sponsor

- Target pERC reconsideration meeting date to be determined