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Zytiga for Metastatic Castration Resistant Prostate Cancer - Details

Project Number PC0028-000
Brand Name Zytiga
Generic Name Abiraterone acetate
Strength 250 mg tablet
Tumour Type Genitourinary
Indication Metastatic Castration Resistant Prostate Cancer
Funding Request For asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC) patients after failure of ADT (have not received prior chemotherapy)
Review Status Complete
Pre Noc Submission Yes
NOC Date May 28, 2013
Manufacturer Janssen Inc.
Sponsor Janssen Inc.
Submission Date March 28, 2013
Submission Deemed Complete April 8, 2013
Submission Type Initial
Prioritization Requested No
Stakeholder Input Deadline ‡ April 15, 2013
Check-point meeting June 24, 2013
pERC Meeting September 19, 2013
Initial Recommendation Issued October 3, 2013
Feedback Deadline ‡ October 18, 2013
Final Recommendation Issued October 22, 2013
Notification to Implement Issued November 6, 2013
Therapeutic Area Metastatic Castration Resistant Prostate Cancer
Recommendation Type Reimburse with clinical criteria and/or conditions

‡ 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.