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

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Initial Recommendation Issued: April 1, 2021

Feedback Deadline: April 16, 2021

Feedback Template: Stakeholder Feedback on a pERC Initial Recommendation 

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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.