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Xtandi for non-metastatic Castration-Resistant Prostate Cancer – Details

Project Number pCODR 10149
Brand Name Xtandi
Generic Name Enzalutamide
Tumour Type Genitourinary
Indication Non-metastatic castration-resistant prostate cancer
Funding Request High risk, non-metastatic castration-resistant prostate cancer
Review Status Under Review
Pre Noc Submission Yes
NOC Date
Manufacturer Astellas Pharma Canada, Inc.
Submitter Astellas Pharma Canada, Inc.
Submission Date September 24, 2018
Submission Deemed Complete October 9, 2018
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ October 9, 2018
Check-point meeting (target date) November 20, 2018
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.