Last Updated : July 31, 2015
Details
FilesGeneric Name:
Enzalutamide
Project Status:
Complete
Therapeutic Area:
First Line Metastatic Castration-Resistant Prostate Cancer
Manufacturer:
Astellas Pharma Canada, Inc.
Brand Name:
Xtandi
Project Line:
Reimbursement Review
Project Number:
PC0044-000
Strength:
40mg capsule
Tumour Type:
Genitourinary
Indications:
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:
Complete
Pre Noc Submission:
Yes
Sponsor:
Astellas Pharma Canada, Inc.
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Requested and Not Granted
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
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.
pERC Meeting:
Final Recommendation Issued:
Files
‡ 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.
Last Updated : July 31, 2015