Last Updated : June 10, 2025
Details
FilesGeneric Name:
ibrutinib
Project Status:
Active
Therapeutic Area:
Hematology
Manufacturer:
N/A
Call for patient/clinician input open:
Brand Name:
N/A
Project Line:
Reimbursement Review
Project Number:
PX0380-000
Call for patient/clinician input closed:
NOC Status at Filing:
N/A
Biosimilar:
No
Submission Complexity:
Standard Review
Fee Schedule:
Pending
Indications:
In combination with immunochemotherapy with or without autologous stem-cell transplantation (ASCT) for previously untreated transplant-eligible patients with mantle cell lymphoma (MCL)
Submission received | 04-Mar-25 |
---|---|
Review initiated | 07-Apr-25 |
Expert committee meeting (initial) | 18-Sep-25 |
Files
Last Updated : June 10, 2025