Last Updated : April 17, 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:
PC0393-000
Call for patient/clinician input closed:
Tumour Type:
Lung
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Rybrevant in combination with carboplatin and pemetrexed for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal-growth factor receptor (EGFR) Exon 19 deletions or Exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with osimertinib.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Rybrevant in combination with carboplatin and pemetrexed for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal-growth factor receptor (EGFR) Exon 19 deletions or Exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with osimertinib.
- 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 | October 04, 2024 |
|---|---|
| Call for patient/clinician input closed | December 02, 2024 |
| Submission received | February 20, 2025 |
| Submission accepted | March 06, 2025 |
| Review initiated | March 07, 2025 |
| Draft CADTH review report(s) provided to sponsor for comment | May 26, 2025 |
| Deadline for sponsors comments | June 04, 2025 |
| CDA-AMC review report(s) and responses to comments provided to sponsor | June 26, 2025 |
| Expert committee meeting (initial) | July 09, 2025 |
| Draft recommendation issued to sponsor | July 21, 2025 To July 23, 2025 |
| Draft recommendation posted for stakeholder feedback | July 29, 2025 |
| End of feedback period | August 13, 2025 |
Files
Last Updated : April 17, 2025