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Apalutamide for Castrate Resistant Prostate Cancer - Details

Project Number pCODR 10133
Brand Name TBD
Generic Name Apalutamide
Tumour Type Genitourinary
Indication Castrate Resistant Prostate Cancer
Funding Request non-metastatic castrate resistant prostate cancer (nm-CRPC)
Review Status Open for Input on Submission
Pre Noc Submission Yes
NOC Date
Manufacturer Janssen Inc.
Submitter Janssen Inc.
Submission Date April 16, 2018
Submission Type New Drug
Prioritization Requested Requested
Stakeholder Input Deadline ‡ April 30, 2018
Check-point meeting (target date)
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.