Last Updated : December 20, 2021
Details
Generic Name:
pembrolizumab and lenvatinib
Project Status:
Withdrawn
Therapeutic Area:
Advanced endometrial cancer
Manufacturer:
Merck Canada
Call for patient/clinician input open:
Brand Name:
Keytruda and Lenvima
Project Line:
Reimbursement Review
Project Number:
PC0271-000
Call for patient/clinician input closed:
Tumour Type:
Genitourinary
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Keytruda (pembrolizumab), as monotherapy, for the treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) endometrial cancer whose tumours have progressed following prior therapy, or in combination with lenvatinib for the treatment of adult patients with advanced endometrial cancer who have disease progression following prior platinum-based systemic therapy in any setting and are not candidates for curative surgery or radiation.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
Keytruda for Adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) endometrial cancer whose tumours have progressed following prior therapy and who have no satisfactory alternative treatment options, as monotherapy. Keytruda, in combination with lenvatinib, is indicated for the treatment of adult patients with advanced endometrial carcinoma who have disease progression following prior platinum-based systemic therapy in any setting and are not candidates for curative surgery or radiation.
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2 | |
|---|---|
| Call for patient/clinician input open | 10-Nov-21 |
| Call for patient/clinician input closed | 07-Jan-22 |
| Clarification: - Patient input submission received from Colorectal Cancer Resource & Action Network (CCRAN), in collaboration with Canadian Cancer Society (CCS) and Canadian Cancer Survivor Network (CCSN). | |
| Submission received | 15-Dec-21 |
| Submission accepted | 07-Jan-22 |
| Clarification: - Submission was not accepted for review on 6 Jan '22 | |
| Review initiated | 10-Jan-22 |
| Clarification: - Voluntarily withdrawn by the sponsor on 07 Mar 2022. | |
Last Updated : December 20, 2021