Tislelizumab (Baizean)

==Mechanism of action==
From the NCI Drug Dictionary: A monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (PD-1), with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, tislelizumab binds to PD-1 and inhibits the binding of PD-1 to the PD-1 ligands programmed cell death-1 ligand 1 (PD-L1), and PD-1 ligand 2 (PD-L2). This prevents the activation of PD-1 and its downstream signaling pathways. This may restore immune function through the activation of both T cells and T-cell-mediated immune responses against tumor cells.
==Diseases for which it is used==
*Esophageal squamous cell carcinoma
*Hepatocellular carcinoma
*Classical Hodgkin lymphoma
*Nasopharyngeal carcinoma
*Non-small cell lung cancer
**Non-small cell lung cancer, nonsquamous
**Non-small cell lung cancer, squamous
*Small cell lung cancer
*Urothelial carcinoma
*MSI-H or dMMR solid tumors (tissue-agnostic)
==History of changes in NMPA indication==
*2019-12-26: Initial approval
*Uncertain date: Full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy.
*Uncertain date: Full approval for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy.
*Uncertain date: Full approval for second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy. 
*Uncertain date: Conditional approval for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies
*Uncertain date: Conditional approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
*Uncertain date: Conditional approval for the treatment of patients with hepatocellular carcinoma (HCC) who have received at least one systemic therapy
*Uncertain date: Conditional approval for the treatment of patients with advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. 
==History of changes in EMA indication==
*2023-09-19: Initial marketing authorization as Tevimbra. Tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy.
==Also known as==
*Code name: BGB-A317
*Generic name: tilelizumab
*Brand names: Baizean, Tevimbra
Category:Drugs
Category:Intravenous medications
Category:Anti-PD-1 antibodies
Category:Esophageal cancer medications
Category:Esophageal squamous cell carcinoma medications
Category:Hepatocellular carcinoma medications
Category:Classical Hodgkin lymphoma medications
Category:Malignant solid neoplasm, MSI-H or dMMR medications
Category:Nasopharyngeal carcinoma medications
Category:Non-small cell lung cancer medications
Category:Non-small cell lung cancer, nonsquamous medications
Category:Non-small cell lung cancer, squamous medications
Category:Small cell lung cancer medications
Category:Urothelial carcinoma medications
Category:NMPA approved in 2019
Category:EMA approved in 2023