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Provide Feedback on Draft Recommendations
Initial Recommendation Issued: April 1, 2021
Feedback Deadline: April 16, 2021
Feedback Template: Stakeholder Feedback on a pERC Initial Recommendation
| Project Number | PC0223-000 |
|---|---|
| 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 | Open for Feedback on Recommendation |
| 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 | Initial |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | October 6, 2020 |
| Check-point meeting | December 2, 2020 |
| pERC Meeting | March 18, 2021 |
| Initial Recommendation Issued | April 1, 2021 |
| Feedback Deadline ‡ | April 16, 2021 |
| pERC Reconsideration Meeting (target date) | |
| Final Recommendation Issued (target date) | |
| Notification to Implement Issued | |
| Therapeutic Area | metastatic castration-resistant prostate cancer (mCRPC) |
‡ 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.
