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Darolutamide (TBD) for Non-Metastatic Castration Resistant Prostate Cancer – Details

Project Number pCODR 10196
Brand Name TBD
Generic Name Darolutamide
Tumour Type Genitourinary
Indication Non-Metastatic Castration Resistant Prostate Cancer
Funding Request In combination with androgen depravation therapy (ADT), for the treatment of patients with non-metastatic castration resistant prostate cancer who are at high risk of developing metastases (high risk defined as prostate-specific antigen doubling time ≤ 10 months) during continuous ADT, and have a good Eastern Cooperative Oncology Group (ECOG) performance status
Review Status Under Review
Pre Noc Submission Yes
NOC Date
Manufacturer Bayer Inc.
Sponsor Bayer Inc.
Submission Date August 27, 2019
Submission Deemed Complete September 11, 2019
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline ‡ September 11, 2019
Check-point meeting November 12, 2019
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.