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| 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 | 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 25, 2020 |
| Submission Type | New Drug |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | April 22, 2020 |
| Check-point meeting | July 20, 2020 |
| 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.