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:
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.
  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 open04-Oct-24
Call for patient/clinician input closed02-Dec-24
Submission received20-Feb-25
Submission accepted06-Mar-25
Review initiated07-Mar-25
Draft CADTH review report(s) provided to sponsor for comment26-May-25
Deadline for sponsors comments04-Jun-25
CADTH review report(s) and responses to comments provided to sponsor26-Jun-25
Expert committee meeting (initial)09-Jul-25
Draft recommendation issued to sponsorJuly 21, 2025
To
July 23, 2025
Draft recommendation posted for stakeholder feedback29-Jul-25
End of feedback period13-Aug-25

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Patient and Clinician Group input View PDF
Last Updated : March 7, 2025