TABLE 3.
Immune checkpoint inhibitors that approved by the China NMPA, US FDA, and EMA
| Drug | The China NMPA‐approved indication | The US FDA‐approved indication | EMA‐approved indication |
|---|---|---|---|
| Pembrolizumab | (1) PD‐L1 TPS ≥ 1%, treatment‐naïve, locally advanced/metastatic NSCLC without EGFR/ALK aberrations; (2) Plus carboplatin and paclitaxel or nab‐paclitaxel for treatment‐naïve, metastatic LUSC; (3) Plus pemetrexed and platinum‐based chemotherapy for treatment‐naïve, metastatic, non‐squamous NSCLC. | (1) PD‐L1 TPS ≥ 1%, treatment‐naïve, locally advanced/metastatic NSCLC without EGFR/ALK aberrations; (2) Plus carboplatin and paclitaxel or nab‐paclitaxel for treatment‐naïve, metastatic LUSC; (3) Plus pemetrexed and platinum‐based chemotherapy for treatment‐naïve, metastatic, non‐squamous NSCLC; (4) Previously platinum‐based chemotherapy treated, advanced/metastatic NSCLC with PD‐L1 positive expression. | (1) PD‐L1 TPS ≥ 50%, treatment‐naïve, locally advanced/metastatic NSCLC without EGFR/ALK aberrations; (2) Plus carboplatin and paclitaxel or nab‐paclitaxel for treatment‐naïve, metastatic LUSC; (3) Plus pemetrexed and platinum‐based chemotherapy for treatment‐naïve, metastatic, non‐squamous NSCLC; (4) Previously chemotherapy treated, locally advanced/metastatic NSCLC with PD‐L1 TPS ≥ 1%. |
| Nivolumab | Previously platinum‐based chemotherapy treated, locally advanced/metastatic NSCLC without EGFR/ALK aberrations. | (1) Previously platinum‐based chemotherapy treated, metastatic NSCLC; (2) Plus ipilimumab and chemotherapy for treatment‐naïve, advanced/relapsed NSCLC; (3) Plus ipilimumab for treatment‐naïve, metastatic NSCLC with PD‐L1 TPS ≥ 1% and without EGFR/ALK aberrations. | (1) Previously chemotherapy treated, locally advanced/metastatic NSCLC; (2) Plus ipilimumab and chemotherapy for treatment‐naïve, metastatic NSCLC. |
| Atezolizumab | (1) PD‐L1 TC ≥ 50% or IC ≥ 10%, treatment‐naïve, metastatic NSCLC without EGFR/ALK aberrations; (2) Plus pemetrexed and platinum‐based chemotherapy for treatment‐naïve, metastatic, non‐squamous NSCLC without EGFR/ALK aberrations. | (1) PD‐L1 TC ≥ 50% or IC ≥ 10%, treatment‐naïve, metastatic NSCLC without EGFR/ALK aberrations; (2) Plus carboplatin and nab‐paclitaxel for treatment‐naïve, metastatic, non‐squamous NSCLC without EGFR/ALK aberrations; (3) Plus bevacizumab and carboplatin and paclitaxel for treatment‐naïve, advanced NSCLC without EGFR/ALK aberrations; (4) Previously platinum‐based chemotherapy treated, metastatic NSCLC; (5) Previously platinum‐based chemotherapy treated, stage II‐IIIA, resected NSCLC with PD‐L1 TC ≥ 1%. | (1) Plus carboplatin and nab‐paclitaxel for treatment‐naïve, metastatic, non‐squamous NSCLC without EGFR/ALK aberrations; (2) Plus bevacizumab and carboplatin and paclitaxel for treatment‐naïve, advanced, non‐squamous NSCLC; (3) Previously chemotherapy treated, locally advanced/metastatic NSCLC. |
| Durvalumab | Stage III, unresectable NSCLC after concurrent chemoradiotherapy. | Stage III, unresectable NSCLC after concurrent chemoradiotherapy. | PD‐L1 TPS ≥ 1%, unresectable NSCLC after concurrent chemoradiotherapy. |
| #Camrelizumab | (1) Plus pemetrexed and carboplatin for treatment‐naïve, advanced, non‐squamous NSCLC without EGFR/ALK aberrations; (2) Plus carboplatin and paclitaxel for treatment‐naïve, advanced LUSC without EGFR/ALK aberrations. | / | / |
| #Sintilimab | (1) Plus pemetrexed and carboplatin for treatment‐naïve, advanced, non‐squamous NSCLC without EGFR/ALK aberrations; (2) Plus gemcitabine and platinum‐based chemotherapy for treatment‐naïve, locally advanced/metastatic LUSC without oncogenic aberrations. | / | / |
| #Tislelizumab | (1) Plus pemetrexed and platinum‐based chemotherapy for treatment‐naïve, locally advanced/metastatic, non‐squamous NSCLC without EGFR/ALK aberrations; (2) Plus carboplatin and paclitaxel or nab‐paclitaxel for treatment‐naïve, advanced LUSC; (3) Previously treated, non‐squamous and squamous NSCLC. | / | / |
| #Sugemalimab | (1) Plus pemetrexed and carboplatin for treatment‐naïve, metastatic, non‐squamous NSCLC without EGFR/ALK aberrations; (2) Plus carboplatin and paclitaxel for treatment‐naïve, metastatic LUSC. | / | / |
Abbreviations: ALK, anaplastic lymphoma kinase; EGFR, epidermal growth factor receptor; EMA, European Medicines Agency; FDA, Food and Drug Administration; IC, immune cells; LUSC, lung squamous cell carcinoma; NMPA, National Medical Products Administration; NSCLC, non‐small cell lung cancer; PD‐L1, programmed death‐ligand 1; TC, tumor cells; TPS, tumor cell proportion score; #, domestic drug.