Generic Name: azacitidine
Brand Name: Onureg
Manufacturer: Celgene Inc., a Bristol-Myers Squibb Company
Therapeutic Area: Acute myeloid leukemia
Indications: Maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment, and who are not eligible for hematopoietic stem cell transplantation (HSCT).
Manufacturer Requested Reimbursement Criteria1: Maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment, and who are not eligible for hematopoietic stem cell transplantation (HSCT).
Submission Type: Initial
Tumour Type: Leukemia
NOC Status at Filing: Post NOC
Project Status: Active
Companion Diagnostics: No
Fee Schedule1: Schedule A
- 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 open | January 29, 2021 |
| Call for patient/clinician input closed | March 26, 2021 |
| Clarification: - Patient input submission received from The Leukemia & Lymphoma Society of Canada | |
| Submission received | March 01, 2021 |
| Submission accepted | March 15, 2021 |
| Review initiated | March 16, 2021 |
| Draft CADTH review report(s) provided to sponsor for comment | June 07, 2021 |
| Deadline for sponsors comments | June 16, 2021 |
| CADTH responses on draft review report(s) provided to sponsor | July 29, 2021 |
| Expert committee meeting (initial) | August 11, 2021 |
| Draft recommendation issued to sponsor | August 23, 2021 To August 25, 2021 |
| Draft recommendation posted for stakeholder feedback | - |