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Last Updated: April 16, 2021
Result type: Reports
Project Number: PC0238-000
Product Line: Reimbursement Review

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

  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 openDecember 03, 2020
Call for patient/clinician input closedJanuary 29, 2021

- Patient input submission received from The Leukemia & Lymphoma Society of Canada

Submission receivedJanuary 08, 2021
Submission acceptedFebruary 05, 2021

- Submission was not accepted for review on 22 Jan 21

Review initiatedFebruary 08, 2021
Draft CADTH review report(s) provided to sponsor for commentApril 27, 2021
Deadline for sponsors commentsMay 06, 2021
CADTH responses on draft review report(s) provided to sponsorMay 31, 2021
Expert committee meeting (initial)June 10, 2021
Draft recommendation issued to sponsorJune 22, 2021
June 24, 2021
Draft recommendation posted for stakeholder feedback-