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Lenvima for Renal Cell Carcinoma – Details

Project Number pCODR 10140
Brand Name Lenvima
Generic Name Lenvatinib
Strength 4mg and 10mg
Tumour Type Genitourinary
Indication Renal Cell Carcinoma (RCC)
Funding Request In combination with everolimus for the treatment of patients with advanced or metastatic, clear-cell RCC following one prior VEGF-targeted therapy.
Review Status Under Review
Pre Noc Submission No
NOC Date September 13, 2017
Manufacturer Eisai Limited
Submitter Eisai Limited
Submission Date June 8, 2018
Submission Deemed Complete June 15, 2018
Submission Type New Indication
Prioritization Requested Requested and Not Granted
Stakeholder Input Deadline ‡ June 22, 2018
Check-point meeting August 14, 2018
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.