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|Project Number||pCODR 10047|
|Funding Request||In combination with paclitaxel and carboplatin for the front-line treatment of epithelial ovarian, fallopian tube or primary peritoneal cancer patients with high risk of relapse (stage III sub-optimally debulked, or stage III unresectable, or stage IV patients|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||Yes|
|Manufacturer||Hoffmann-La Roche Limited|
|Sponsor||Hoffmann-La Roche Limited|
|Submission Date||November 28, 2014|
|Submission Deemed Complete||December 5, 2014|
|Submission Type||New Indication|
|Prioritization Requested||Requested and Not Granted|
|Stakeholder Input Deadline ‡||December 12, 2014|
|Check-point meeting||January 26, 2015|
|pERC Meeting||March 19, 2015|
|Initial Recommendation Issued||April 2, 2015|
|Feedback Deadline ‡||April 17, 2015|
|pERC Reconsideration Meeting||May 21, 2015|
|Final Recommendation Issued||June 4, 2015|
|Notification to Implement Issued||June 19, 2015|
‡ 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.