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Erleada for Castrate Resistant Prostate Cancer - Details

Project Number pCODR 10133
Brand Name Erleada
Generic Name Apalutamide
Strength 60 mg
Tumour Type Genitourinary
Indication Castrate Resistant Prostate Cancer
Funding Request non-metastatic castrate resistant prostate cancer (nm-CRPC)
Review Status Under Review
Pre Noc Submission Yes
NOC Date July 3, 2018
Manufacturer Janssen Inc.
Submitter Janssen Inc.
Submission Date April 16, 2018
Submission Deemed Complete May 1, 2018
Submission Type New Drug
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ April 30, 2018
Check-point meeting June 12, 2018
pERC Meeting August 16, 2018
Initial Recommendation Issued August 30, 2018
Feedback Deadline ‡ September 14, 2018
pERC Reconsideration Meeting October 18, 2018
Final Recommendation Issued (target date) November 1, 2018
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.