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

Project Number pCODR 10209
Brand Name Xtandi
Generic Name Enzalutamide
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 Under Review
Pre Noc Submission Yes
NOC Date
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 (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.