Erleada for Castrate Resistant Prostate Cancer - Details

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Generic Name:
Apalutamide
Project Status:
Complete
Therapeutic Area:
non-metastatic castrate resistant prostate cancer (nm-CRPC)
Manufacturer:
Janssen Inc.
Brand Name:
Erleada
Project Line:
Reimbursement Review
Project Number:
PC0133-000
NOC Status at Filing:
Pre NOC
Strength:
60 mg
Tumour Type:
Genitourinary
Indications:
Castrate Resistant Prostate Cancer
Funding Request:
non-metastatic castrate resistant prostate cancer (nm-CRPC)
Pre Noc Submission:
Yes
Sponsor:
Janssen Inc.
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Requested and Granted
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:

‡ 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.