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Lenvima for Differentiated Thyroid Cancer – Details

Project Number PC0080-000
Brand Name Lenvima
Generic Name Lenvatinib
Strength 4mg and 10mg Capsules
Tumour Type Endocrine
Indication Differentiated Thyroid Cancer
Funding Request For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory DTC
Review Status Complete
Pre Noc Submission No
NOC Date December 22, 2015
Manufacturer Eisai Limited
Sponsor Eisai Limited
Submission Date April 18, 2016
Submission Deemed Complete April 25, 2016
Submission Type Initial
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ May 2, 2016
Check-point meeting June 15, 2016
pERC Meeting August 18, 2016
Initial Recommendation Issued September 1, 2016
Feedback Deadline ‡ September 16, 2016
Final Recommendation Issued September 20, 2016
Notification to Implement Issued October 5, 2016
Therapeutic Area Differentiated Thyroid Cancer
Recommendation Type Reimburse with clinical criteria and/or conditions

‡ 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.