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| Project Number | PC0210-000 |
|---|---|
| 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 | Complete |
| 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 | Initial |
| 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 | January 25, 2021 |
| Therapeutic Area | Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) |
| Recommendation Type | Reimburse with clinical criteria and/or conditions |
‡ 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.
