Generic Name:
cemiplimab
Project Status:
Active
Therapeutic Area:
Non-small cell lung cancer
Manufacturer:
Sanofi Genzyme, a division of Sanofi-Aventis Canada Inc.
Brand Name:
Libtayo
Project Line:
Reimbursement Review
Project Number:
PC0262-000
Tumour Type:
Lung
NOC Status at Filing:
Pre NOC
Details
Manufacturer Requested Reimbursement Criteria1:
For the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 in ≥ 50% of tumour cells (Tumour Proportion Score [TPS] ≥ 50%), as determined by a validated test, with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 in ≥ 50% of tumour cells (Tumour Proportion Score [TPS] ≥ 50%), as determined by a validated test, with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC.
- 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.