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Apalutamide (Erleada) for Metastatic Castration-Sensitive Prostate Cancer - Details

Project Number pCODR 10200
Brand Name Erleada
Generic Name Apalutamide
Strength 60 mg
Tumour Type Genitourinary
Indication Metastatic Castration-Sensitive Prostate Cancer
Funding Request For the treatment of metastatic castration-sensitive prostate cancer (mCSPC)
Review Status Under Review
Pre Noc Submission Yes
NOC Date December 12, 2019
Manufacturer Janssen Inc.
Sponsor Janssen Inc.
Submission Date October 15, 2019
Submission Deemed Complete October 29, 2019
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ October 29, 2019
Check-point meeting December 17, 2019
pERC Meeting (target date) March 19, 2020
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.