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Cabometyx for Renal Cell Carcinoma Resubmission – Details

Project Number PC0163-000
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 Complete
Pre Noc Submission No
NOC Date September 14, 2018
Manufacturer Ipsen Biopharmaceuticals Canada Inc.
Sponsor 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 January 31, 2019
Feedback Deadline ‡ February 14, 2019
Final Recommendation Issued February 20, 2019
Notification to Implement Issued March 7, 2019
Therapeutic Area Renal Cell Carcinoma (RCC)
Recommendation Type Reimburse with clinical criteria and/or conditions

‡ 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.