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Lenvima for Hepatocellular Carcinoma – Details

Project Number pCODR 10175
Brand Name Lenvima
Generic Name Lenvatinib
Tumour Type Gastrointestinal
Indication Hepatocellular Carcinoma
Funding Request For the first-line treatment of adult patients with unresectable Hepatocellular Carcinoma (HCC)
Review Status Pending
Pre Noc Submission No
NOC Date
Manufacturer Eisai Limited
Submitter Eisai Limited
Submission Date (Target Date) January 31, 2019
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline (target date based on target submission date) ‡ February 14, 2019
Check-point meeting (target date)
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.