Last Updated : July 31, 2024
Details
FilesGeneric Name:
sotorasib
Project Status:
Complete
Therapeutic Area:
KRAS G12C-mutated advanced NSCLC
Manufacturer:
Amgen Canada Inc.
Brand Name:
Lumakras
Project Line:
Reimbursement Review
Project Number:
PC0300-000
Tumour Type:
Lung
NOC Status at Filing:
Post NOC
Performance Metric:
N/A delay outside our control - Temporary suspension and/or submission of new information by sponsor
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Treatment of adult patients with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C-mutated locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
Treatment of adult patients with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C-mutated locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy.
Date NOC Issued:
Recommendation Type:
Do not reimburse
Final Recommendation:
- 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.
| Call for patient/clinician input open | 21-Jul-22 |
|---|---|
| Call for patient/clinician input closed | 12-Sep-22 |
| Clarification: - Patient input submission received from Lung Cancer Canada, Lung Health Foundation, and Canadian Cancer Survivor Network. | |
| Submission received | 19-Aug-22 |
| Submission accepted | 02-Sep-22 |
| Review initiated | 06-Sep-22 |
| Draft CADTH review report(s) provided to sponsor for comment | 20-Jul-23 |
| Clarification: - Submission temporarily suspended - Additional information has been received and the temporary suspension of the review has been lifted | |
| Deadline for sponsors comments | 31-Jul-23 |
| CADTH review report(s) and responses to comments provided to sponsor | 31-Aug-23 |
| Expert committee meeting (initial) | 13-Sep-23 |
| Draft recommendation issued to sponsor | 27-Sep-23 |
| Draft recommendation posted for stakeholder feedback | 05-Oct-23 |
| End of feedback period | 20-Oct-23 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | 14-Feb-24 |
| Final recommendation posted | 19-Mar-24 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 14-Mar-24 |
| CADTH review report(s) posted | 23-Jul-24 |
Files
Last Updated : July 31, 2024