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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 Final Recommendation Posted
Pre Noc Submission No
NOC Date November 28, 2019
Manufacturer AstraZeneca Canada Inc.
Sponsor AstraZeneca Canada Inc.
Submission Date April 7, 2020
Submission Deemed Complete May 25, 2020
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline ‡ April 22, 2020
Check-point meeting July 20, 2020
pERC Meeting October 15, 2020
Initial Recommendation Issued October 29, 2020
Feedback Deadline ‡ November 12, 2020
pERC Reconsideration Meeting December 17, 2020
Final Recommendation Issued January 8, 2021
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.