Last Updated : January 29, 2025
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
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/Report:
- 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 | July 21, 2022 |
|---|---|
| Call for patient/clinician input closed | September 12, 2022 |
| Clarification: - Patient input submission received from Lung Cancer Canada, Lung Health Foundation, and Canadian Cancer Survivor Network. | |
| Submission received | August 19, 2022 |
| Submission accepted | September 02, 2022 |
| Review initiated | September 06, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | July 20, 2023 |
| Clarification: - Submission temporarily suspended - Additional information has been received and the temporary suspension of the review has been lifted | |
| Deadline for sponsors comments | July 31, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | August 31, 2023 |
| Expert committee meeting (initial) | September 13, 2023 |
| Draft recommendation issued to sponsor | September 27, 2023 |
| Draft recommendation posted for stakeholder feedback | October 05, 2023 |
| End of feedback period | October 20, 2023 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | February 14, 2024 |
| Final recommendation posted | March 19, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | March 14, 2024 |
| CADTH review report(s) posted | July 23, 2024 |
Files
Last Updated : January 29, 2025