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Cabometyx for Renal Cell Carcinoma Resubmission – Details

Project Number pCODR 10163
Brand Name Cabometyx
Generic Name Cabozantinib
Strength 20 mg, 40 mg & 60 mg
Tumour Type Genitourinary
Indication Renal Cell Carcinoma
Funding Request For the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior therapy.
Review Status Under Review
Pre Noc Submission No
NOC Date September 14, 2018
Manufacturer Ipsen Biopharmaceuticals Canada Inc.
Submitter Ipsen Biopharmaceuticals Canada Inc.
Submission Date September 17, 2018
Submission Deemed Complete October 2, 2018
Submission Type Resubmission
Prioritization Requested
Stakeholder Input Deadline ‡ October 2, 2018
Check-point meeting November 6, 2018
pERC Meeting January 17, 2019
Initial Recommendation Issued (target date) January 31, 2019
Feedback Deadline (target date) ‡ February 14, 2019
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.