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Abiraterone (Zytiga) for Prostate Cancer Resubmission - Details

Project Number PC0201-000
Brand Name Zytiga (Resubmission)
Generic Name Abiraterone
Strength 250 mg & 500 mg
Tumour Type Genitourinary
Indication Prostate Cancer
Funding Request Newly diagnosed high-risk metastatic castration sensitive prostate cancer without small-cell histologic features. Patients required to have at least two of the three following high-risk factors: Gleason score of 8 or more, at least 3 bone lesions, and presence of visceral metastasis. Less than 3 months of androgen deprivation therapy (or orchiectomy) for metastatic disease. Eligible for abiraterone therapy.
Review Status On Hold
Clarification The timeline of the review has been temporarily suspended, pending the receipt of additional information from the sponsor.
Pre Noc Submission No
NOC Date February 15, 2018
Manufacturer Janssen Inc.
Sponsor BC Cancer Agency
Submission Date July 29, 2019
Submission Deemed Complete October 29, 2019
Submission Type Initial
Prioritization Requested
Stakeholder Input Deadline ‡ August 13, 2019
Check-point meeting (target date)
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
Therapeutic Area Prostate Cancer Resubmission

‡ 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.