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Lenvima for Hepatocellular Carcinoma – Details

Project Number pCODR 10175
Brand Name Lenvima
Generic Name Lenvatinib
Strength 4 mg & 12 mg
Tumour Type Gastrointestinal
Indication Hepatocellular Carcinoma
Funding Request For the first-line treatment of adult patients with unresectable Hepatocellular Carcinoma (HCC)
Review Status Notification to Implement Issued
Pre Noc Submission No
NOC Date December 19, 2018
Manufacturer Eisai Limited
Sponsor Eisai Limited
Submission Date February 8, 2019
Submission Deemed Complete February 25, 2019
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ February 25, 2019
Check-point meeting April 12, 2019
pERC Meeting June 20, 2019
Initial Recommendation Issued July 5, 2019
Feedback Deadline ‡ July 19, 2019
Final Recommendation Issued July 24, 2019
Notification to Implement Issued August 9, 2019

‡ 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.