Generic Name: venetoclax
Brand Name: Venclexta
Manufacturer: AbbVie Corporation
Therapeutic Area: Acute myeloid leukemia
Indications: Venclexta is indicated, in combination with a hypomethylating agent or in combination with low-dose cytarabine, in adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.
Manufacturer Requested Reimbursement Criteria1: In combination with azacitidine for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
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 | December 03, 2020 |
| Call for patient/clinician input closed | January 29, 2021 |
| Clarification: - Patient input submission received from The Leukemia & Lymphoma Society of Canada | |
| Submission received | January 08, 2021 |
| Submission accepted | February 05, 2021 |
| Clarification: - Submission was not accepted for review on 22 Jan 21 | |
| Review initiated | February 08, 2021 |
| Draft CADTH review report(s) provided to sponsor for comment | April 27, 2021 |
| Deadline for sponsors comments | May 06, 2021 |
| CADTH responses on draft review report(s) provided to sponsor | May 31, 2021 |
| Expert committee meeting (initial) | June 10, 2021 |
| Draft recommendation issued to sponsor | June 22, 2021 To June 24, 2021 |
| Draft recommendation posted for stakeholder feedback | - |