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Cabozantinib for Advanced Renal Cell Carcinoma – Details

Project Number PC0123-000
Brand Name TBD
Generic Name Cabozantinib
Tumour Type Genitourinary
Indication Renal Cell Carcinoma (RCC)
Funding Request For the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior therapy
Review Status Withdrawn
Pre Noc Submission Yes
NOC Date
Manufacturer Ipsen Biopharmaceuticals Canada Inc.
Sponsor Ipsen Biopharmaceuticals Canada Inc.
Clarification Ipsen Biopharmaceuticals Canada Inc. has notified pCODR that the Category 2 submission requirements for the pre NOC submission of Cabozantinib (Cabometyx) RCC cannot be met at this time. As per pCODR Procedures C3.1.6, the pCODR program has stopped the review.
Submission Date October 6, 2017
Submission Deemed Complete October 16, 2017
Submission Type Initial
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ October 23, 2017
Check-point meeting November 27, 2017
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.