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Acalabrutinib (Calquence) for previously untreated chronic lymphocytic leukemia - Details

Project Number pCODR 10210
Brand Name Calquence
Generic Name Acalabrutinib
Strength 100 mg
Tumour Type Leukemia
Indication Chronic Lymphocytic Leukemia (CLL) (previously untreated)
Funding Request With or without obinutuzumab, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL) for whom a fludarabine-based regimen is inappropriate.
Review Status Pending
Pre Noc Submission No
NOC Date November 28, 2019
Manufacturer AstraZeneca Canada Inc.
Sponsor AstraZeneca Canada Inc.
Submission Date (Target Date) April 3, 2020
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline (target date based on target submission date) ‡ April 20, 2020
Check-point meeting (target date)
pERC Meeting (target date)
Initial Recommendation Issued (target date)
Feedback Deadline (target date) ‡
pERC Reconsideration Meeting (target date)
Final Recommendation Issued (target date)
Notification to Implement Issued

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.