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| Project Number | pCODR 10223 |
|---|---|
| Brand Name | Lynparza |
| Generic Name | Olaparib |
| Strength | 100 mg and 150 mg |
| Tumour Type | Genitourinary |
| Indication | Metastatic Castration-Resistant Prostate Cancer (mCRPC) |
| Funding Request | As monotherapy for the treatment of adult patients with mCRPC and deleterious or suspected deleterious germline and/or somatic mutations in the HRR genes BRCA or ATM who have progressed following prior treatment with a NHA. |
| Review Status | Under Review |
| Pre Noc Submission | No |
| NOC Date | August 21, 2020 |
| Manufacturer | AstraZeneca Canada Inc. |
| Sponsor | AstraZeneca Canada Inc. |
| Submission Date | September 22, 2020 |
| Submission Deemed Complete | October 6, 2020 |
| Submission Type | New Indication |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | October 6, 2020 |
| Check-point meeting | December 2, 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.