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Enzalutamide (Xtandi) for Metastatic Castration Sensitive Prostate Cancer - Details

Project Number pCODR 10209
Brand Name Xtandi
Generic Name Enzalutamide
Strength 40mg
Tumour Type Genitourinary
Indication Metastatic Castration Sensitive Prostate Cancer (mCSPC)
Funding Request For the treatment of patients with metastatic castration sensitive prostate cancer
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date June 2, 2020
Manufacturer Astellas Pharma Canada, Inc.
Sponsor Astellas Pharma Canada, Inc.
Submission Date February 24, 2020
Submission Deemed Complete March 12, 2020
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ March 9, 2020
Check-point meeting April 23, 2020
pERC Meeting August 20, 2020
Initial Recommendation Issued September 3, 2020
Feedback Deadline ‡ September 18, 2020
pERC Reconsideration Meeting (target date)
Final Recommendation Issued September 23, 2020
Notification to Implement Issued October 8, 2020

‡ 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.