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Xtandi First Line mCRPC - Details

Project Number pCODR 10044
Brand Name Xtandi
Generic Name Enzalutamide
Strength 40mg capsule
Tumour Type Genitourinary
Indication First Line Metastatic Castration-Resistant Prostate Cancer
Funding Request Treatment of patients with metastatic castration-resistant prostrate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy who have not received prior chemotherapy
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date April 15, 2015
Manufacturer Astellas Pharma Canada, Inc.
Submitter Astellas Pharma Canada, Inc.
Submission Date October 2, 2014
Submission Deemed Complete October 9, 2014
Submission Type New Indication
Prioritization Requested Requested and Not Granted
Stakeholder Input Deadline ‡ October 17, 2014
Check-point meeting February 2, 2015
pERC Meeting May 21, 2015
Clarification The Manufacturer had advised that Category 2 submission requirements for a pre-NOC submission were not available to complete the submission for an April pERC meeting date. An updated target date for the pERC meeting had been set by pCODR, based on the anticipated timing of the manufacturer being able to provide these outstanding submission requirements. A confirmed pERC meeting date is posted as all pre-NOC submission requirements have been met.
Initial Recommendation Issued June 4, 2015
Feedback Deadline ‡ June 18, 2015
Final Recommendation Issued June 22, 2015
Notification to Implement Issued July 8, 2015

‡ 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.