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Cabozantinib (Cabometyx) for Hepatocellular Carcinoma - Details

Project Number pCODR 10186
Brand Name Cabometyx
Generic Name Cabozantinib
Strength 20 mg, 40 mg & 60 mg
Tumour Type Gastrointestinal
Indication Hepatocellular Carcinoma
Funding Request For the treatment of Hepatocellular Carcinoma (HCC) in adults after prior therapy
Review Status Under Review
Pre Noc Submission Yes
NOC Date November 8, 2019
Manufacturer Ipsen Biopharmaceuticals Canada Inc.
Sponsor Ipsen Biopharmaceuticals Canada Inc.
Submission Date October 16, 2019
Submission Deemed Complete October 30, 2019
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ October 30, 2019
Check-point meeting (target date) January 8, 2020
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.