Last Updated : October 12, 2022
Details
FilesGeneric Name:
lenvatinib and pembrolizumab
Project Status:
Complete
Therapeutic Area:
advanced or metastatic renal cell carcinoma
Manufacturer:
Eisai Limited
Brand Name:
Lenvima and Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0268-000
Tumour Type:
Genitourinary
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Lenvatinib, in combination with pembrolizumab, for the treatment of adult patients with advanced or metastatic RCC with no prior systemic therapy for metastatic RCC.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Lenvatinib, in combination with pembrolizumab, for the treatment of adult patients with advanced or metastatic RCC with no prior systemic therapy for metastatic RCC.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2 |
|
|---|---|
| Call for patient/clinician input open | 18-Oct-21 |
| Call for patient/clinician input closed | 09-Dec-21 |
| Clarification:
- Patient input submission received from CanCertainty and Kidney Cancer Canada (KCC) |
|
| Submission received | 15-Nov-21 |
| Submission accepted | |
| Review initiated | 30-Nov-21 |
| Draft CADTH review report(s) provided to sponsor for comment | 01-Mar-22 |
| Deadline for sponsors comments | 10-Mar-22 |
| CADTH review report(s) and responses to comments provided to sponsor | 01-Apr-22 |
| Expert committee meeting (initial) | 13-Apr-22 |
| Draft recommendation issued to sponsor | 17-May-22 |
| Clarification:
- pERC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements. |
|
| Draft recommendation posted for stakeholder feedback | 26-May-22 |
| End of feedback period | 09-June-22 |
| Transmission de la recommandation définitive au promoteur et aux régimes d'assurance | 23-Jun-22 |
| Final recommendation posted | 12-Jul-22 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 08-Jul-22 |
| CADTH review report(s) posted | 11-Oct-22 |
Files
Last Updated : October 12, 2022