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| Project Number | pCODR 10080 |
|---|---|
| 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 | Notification to Implement Issued |
| 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 | New Drug |
| 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 |
‡ 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.
