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. 2023 Feb 16;16:22. doi: 10.1186/s40545-023-00529-0

Table 2.

Dates of approval and reimbursement of pembrolizumab

Indication FDA approval NICE, England PBAS, Australia The National Advisory Committee for the Basket of Health Services, Israel
2L after disease progression with chemotherapy with PD-L1 TPS ≥ 1% October 2015 January 2017 (Rejected in 2016) January 2018
1L monotherapy for TPS ≥ 50% October 2016 June 2017 July 2018 (with PS 0–1) January 2017
1L in combination with chemotherapy—non-squamous cell carcinoma August 2018 January 2019 July 2019 (with PS 0–1) January 2019
1L in combination with chemotherapy—squamous cell carcinoma October 2018 September 2019 January 2019

FDA Food and Drug Administration, NICE The National Institute for Health and Care Excellence, PBAC Pharmaceutical Benefits Advisory Committee, 1L first line, 2L second line, PD-L1 programmed death-ligand 1, TPS tumor proportion score, PS performance score