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Xtandi for metastatic Castration Resistant Prostate Cancer - Details

Project Number pCODR 10023
Brand Name Xtandi
Generic Name Enzalutamide
Strength 40 mg tablet
Tumour Type Genitourinary
Indication Metastatic Castration Resistant Prostate Cancer
Funding Request For the treatment of patients with metastatic castration-resistant prostate cancer, who have previously received docetaxel therapy
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date May 29, 2013
Manufacturer Astellas Pharma Canada Inc.
Submitter Astellas Pharma Canada Inc.
Submission Date March 4, 2013
Submission Deemed Complete March 19, 2013
Submission Type New Drug
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ March 18, 2013
Check-point meeting April 30, 2013
pERC Meeting June 20, 2013
Initial Recommendation Issued July 5, 2013
Feedback Deadline ‡ July 19, 2013
Final Recommendation Issued July 23, 2013
Notification to Implement Issued August 8, 2013

‡ 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.