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Lenvima for Renal Cell Carcinoma – Details

Project Number PC0140 -000
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 Complete
Pre Noc Submission No
NOC Date September 13, 2017
Manufacturer Eisai Limited
Sponsor Eisai Limited
Submission Date June 8, 2018
Submission Deemed Complete June 15, 2018
Submission Type Initial
Prioritization Requested Requested and Not Granted
Stakeholder Input Deadline ‡ June 22, 2018
Check-point meeting August 14, 2018
pERC Meeting October 18, 2018
Initial Recommendation Issued November 1, 2018
Feedback Deadline ‡ November 15, 2018
pERC Reconsideration Meeting December 13, 2018
Final Recommendation Issued January 4, 2019
Notification to Implement Issued January 21, 2019
Therapeutic Area Renal Cell Carcinoma (RCC)
Recommendation Type Do not reimburse

‡ 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.