Canada’s Drug Agency | Drugs, Health Technologies and Systems.
Canada’s Drug Agency | Drugs, Health Technologies and Systems.

amivantamab

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Generic 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
Performance Metric:
Achieved
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:
  1. 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 open10-May-24
Call for patient/clinician input closed08-Jul-24
Submission received21-Jun-24
Submission accepted08-Jul-24
Review initiated09-Jul-24
Draft CADTH review report(s) provided to sponsor for comment23-Sep-24
Deadline for sponsors comments03-Oct-24
CADTH review report(s) and responses to comments provided to sponsor31-Oct-24
Expert committee meeting (initial)13-Nov-24
Draft recommendation issued to sponsor27-Nov-24
Draft recommendation posted for stakeholder feedback05-Dec-24
End of feedback period19-Dec-24
Final recommendation issued to sponsor and drug plans10-Jan-25
Final recommendation posted29-Jan-25
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)27-Jan-25
CADTH review report(s) posted-

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Recommendation and Reason View PDF
Patient and Clinician Group input View PDF
Last Updated : January 29, 2025