tepotinib


( Last Updated : September 20, 2021)
Generic Name:
tepotinib
Project Status:
Active
Therapeutic Area:
Locally advanced or metastatic non-small cell lung cancer
Manufacturer:
EMD Serono Canada, a division of EMD Inc.
Call for patient/clinician input open:
Brand Name:
Tepmetko
Project Line:
Reimbursement Review
Project Number:
PC0255-000
Call for patient/clinician input closed:
Tumour Type:
Lung
NOC Status at Filing:
Post NOC

Details


Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring METexon14 skipping alterations.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​For the treatment of adult patients with locally advanced unresectable metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET) tyrosine kinase receptor exon 14 skipping alterations.
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient/clinician input open29-Jul-21
Call for patient/clinician input closed20-Sep-21
Submission received30-Aug-21
Submission accepted14-Sep-21
Review initiated15-Sep-21
Draft CADTH review report(s) provided to sponsor for comment29-Nov-21
Deadline for sponsors comments08-Dec-21
CADTH review report(s) and responses to comments provided to sponsor28-Jan-22
Expert committee meeting (initial)09-Feb-22
Draft recommendation issued to sponsor
Draft recommendation posted for stakeholder feedback