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


( Last Updated : May 7, 2020)
Generic Name:
Darolutamide
Project Status:
Complete
Therapeutic Area:
non-metastatic castration resistant prostate cancer (nmCRPC)
Manufacturer:
Bayer Inc.
Brand Name:
Nubeqa
Project Line:
Reimbursement Review
Project Number:
PC0196-000
NOC Date:

Details


Strength:
300 mg
Tumour Type:
Genitourinary
Indications:
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:
Complete
Pre Noc Submission:
Yes
Sponsor:
Bayer Inc.
Submission Date:
Submission Deemed Complete:
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
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.