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

Project Number PC0149-000
Brand Name Xtandi
Generic Name Enzalutamide
Strength 40 mg
Tumour Type Genitourinary
Indication Non-metastatic castration-resistant prostate cancer
Funding Request High risk, non-metastatic castration-resistant prostate cancer
Review Status Complete
Pre Noc Submission Yes
NOC Date December 20, 2018
Manufacturer Astellas Pharma Canada, Inc.
Sponsor Astellas Pharma Canada, Inc.
Submission Date September 24, 2018
Submission Deemed Complete October 9, 2018
Submission Type Initial
Prioritization Requested
Stakeholder Input Deadline ‡ October 9, 2018
Check-point meeting November 20, 2018
pERC Meeting February 21, 2019
Initial Recommendation Issued March 7, 2019
Feedback Deadline ‡ March 21, 2019
Final Recommendation Issued March 26, 2019
Notification to Implement Issued April 10, 2019
Therapeutic Area Non-metastatic castration-resistant prostate cancer (nm-CRPC)
Recommendation Type Reimburse with clinical criteria and/or conditions

‡ 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.