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) in combination with RYBREVANT® (amivantamab) is indicated 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 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) in combination with amivantamab is indicated 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 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 openOctober 04, 2024
Call for patient/clinician input closedDecember 02, 2024
Submission receivedDecember 18, 2024
Submission acceptedJanuary 09, 2025
Review initiatedJanuary 10, 2025
Draft CADTH review report(s) provided to sponsor for commentMarch 28, 2025
Deadline for sponsors commentsApril 08, 2025
CDA-AMC review report(s) and responses to comments provided to sponsorMay 02, 2025
Expert committee meeting (initial)May 14, 2025
Draft recommendation issued to sponsorMay 27, 2025
To
May 29, 2025
Draft recommendation posted for stakeholder feedbackJune 05, 2025
End of feedback periodJune 19, 2025

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Patient and Clinician Group input View PDF
Last Updated : April 17, 2025