selinexor

Details

Files
Generic Name:
selinexor
Project Status:
Complete
Therapeutic Area:
Multiple myeloma
Manufacturer:
FORUS Therapeutics Inc.
Call for patient/clinician input open:
Brand Name:
Xpovio
Project Line:
Reimbursement Review
Project Number:
PC0276-000
Call for patient/clinician input closed:
Tumour Type:
Myeloma
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
As per indication to be reviewed by CADTH: In combination with bortezomib (V) and dexamethasone (d) for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​In combination with bortezomib (V) and dexamethasone (d) for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy.
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones

Call for patient/clinician input open09-Dec-21
Call for patient/clinician input closed04-Feb-22
Clarification:

- Patient input submission received from Myeloma Canada

Submission received14-Jan-22
Submission accepted28-Jan-22
Review initiated01-Feb-22
Draft CADTH review report(s) provided to sponsor for comment18-Apr-22
Deadline for sponsors comments27-Apr-22
CADTH responses on draft review report(s) provided to sponsor27-May-22
Expert committee meeting (initial)08-Jun-22
Draft recommendation issued to sponsor22-Jun-22
Draft recommendation posted for stakeholder feedback30-Jun-22
End of feedback period15-Jul-22
Final recommendation issued to sponsor and drug plans29-Jul-22
Final recommendation posted17-Aug-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)15-Aug-22
CADTH review report(s) posted13-Oct-22