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|Project Number||pCODR 10201|
|Brand Name||Zytiga (Resubmission)|
|Strength||250 mg & 500 mg|
|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.|
|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|
|Sponsor||BC Cancer Agency|
|Submission Date||July 29, 2019|
|Submission Deemed Complete||October 29, 2019|
|Submission Type||New Indication|
|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|
‡ 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.