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Olaparib (Lynparza) for metastatic castration-resistant prostate cancer - Details

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.