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| Project Number | pCODR 10211 |
|---|---|
| Brand Name | Calquence |
| Generic Name | Acalabrutinib |
| Strength | 100 mg |
| Tumour Type | Leukemia |
| Indication | Chronic Lymphocytic Leukemia (CLL) |
| Funding Request | As monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. |
| Review Status | Under Review |
| 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 13, 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 (target date) | October 29, 2020 |
| Feedback Deadline (target date) ‡ | November 12, 2020 |
| 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.
