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

lazertinib and amivantamab

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Generic Name:
lazertinib and 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:
Lazcluze and Rybrevant
Project Line:
Reimbursement Review
Project Number:
PC0392-000
Call for patient/clinician input closed:
Tumour Type:
Lung
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
LAZCLUZE® (lazertinib) tablets in combination with RYBREVANT® (amivantamab) for the first-line treatment of adult patients with locally advanced (not amenable to curative therapy) or metastatic non-small lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
LAZCLUZE® (lazertinib) tablets in combination with RYBREVANT® (amivantamab) for the first-line treatment of adult patients with locally advanced (not amenable to curative therapy) or metastatic non-small lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.
  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 received18-Dec-24
Submission accepted09-Jan-25
Review initiated10-Jan-25
Draft CADTH review report(s) provided to sponsor for comment28-Mar-25
Deadline for sponsors comments08-Apr-25
CADTH review report(s) and responses to comments provided to sponsor02-May-25
Expert committee meeting (initial)14-May-25
Draft recommendation issued to sponsorMay 27, 2025
To
May 29, 2025
Draft recommendation posted for stakeholder feedback05-Jun-25
End of feedback period19-Jun-25

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Patient and Clinician Group input View PDF
Last Updated : January 10, 2025