Last Updated : February 3, 2025
Details
FilesGeneric Name:
amivantamab
Project Status:
Active
Therapeutic Area:
Locally advanced or metastatic non-small cell lung cancer (NSCLC)
Manufacturer:
Janssen Inc
Call for patient/clinician input open:
Brand Name:
Rybrevant
Project Line:
Reimbursement Review
Project Number:
PC0376-000
Call for patient/clinician input closed:
Tumour Type:
Lung
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Rybrevant in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with activating epidermal-growth factor receptor (EGFR) exon 20 insertion mutations.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
Rybrevant in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with activating epidermal-growth factor receptor (EGFR) exon 20 insertion mutations.
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 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 | May 10, 2024 |
|---|---|
| Call for patient/clinician input closed | July 08, 2024 |
| Submission received | June 21, 2024 |
| Submission accepted | July 08, 2024 |
| Review initiated | July 09, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | September 23, 2024 |
| Deadline for sponsors comments | October 03, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | October 31, 2024 |
| Expert committee meeting (initial) | November 13, 2024 |
| Draft recommendation issued to sponsor | November 27, 2024 |
| Draft recommendation posted for stakeholder feedback | December 05, 2024 |
| End of feedback period | December 19, 2024 |
| Final recommendation issued to sponsor and drug plans | January 10, 2025 |
| Final recommendation posted | January 29, 2025 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | January 27, 2025 |
| CADTH review report(s) posted | - |
Files
Last Updated : February 3, 2025