Difference between revisions of "Tislelizumab (Baizean)"
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Warner-admin (talk | contribs) m (Text replacement - "[[Category:Hodgkin lymphoma " to "[[Category:Classical Hodgkin lymphoma ") |
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==Mechanism of action== | ==Mechanism of action== | ||
From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/tislelizumab 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. | From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/tislelizumab 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== | ==Diseases for which it is used== | ||
− | |||
*[[Esophageal squamous cell carcinoma]] | *[[Esophageal squamous cell carcinoma]] | ||
*[[Hepatocellular carcinoma]] | *[[Hepatocellular carcinoma]] | ||
− | *[[Hodgkin lymphoma]] | + | *[[Classical Hodgkin lymphoma]] |
*[[Nasopharyngeal carcinoma]] | *[[Nasopharyngeal carcinoma]] | ||
*[[Non-small cell lung cancer]] | *[[Non-small cell lung cancer]] | ||
**[[Non-small cell lung cancer, nonsquamous]] | **[[Non-small cell lung cancer, nonsquamous]] | ||
**[[Non-small cell lung cancer, squamous]] | **[[Non-small cell lung cancer, squamous]] | ||
+ | *[[Urothelial carcinoma]] | ||
+ | *[[Malignant solid neoplasm, MSI-H or dMMR|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 [[Non-small cell lung cancer, squamous|squamous non-small cell lung cancer (NSCLC)]] in combination with chemotherapy. | ||
+ | *Uncertain date: Full approval for first-line treatment of patients with advanced [[Non-small cell lung cancer, nonsquamous|non-squamous NSCLC]] in combination with chemotherapy. | ||
+ | *Uncertain date: Full approval for second- or third-line treatment of patients with locally advanced or metastatic [[Non-small cell lung cancer|NSCLC]] who progressed on prior platinum-based chemotherapy. | ||
+ | *Uncertain date: Conditional approval for the treatment of patients with [[Classical Hodgkin lymphoma|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|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|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) [[:Category:Malignant solid neoplasm|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 [[Esophageal squamous cell carcinoma|oesophageal squamous cell carcinoma]] after prior platinum-based chemotherapy. | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' BGB-A317 | *'''Code name:''' BGB-A317 | ||
+ | *'''Generic name:''' tilelizumab | ||
+ | *'''Brand names:''' Baizean, Tevimbra | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
Line 20: | Line 35: | ||
[[Category:Anti-PD-1 antibodies]] | [[Category:Anti-PD-1 antibodies]] | ||
− | |||
[[Category:Esophageal cancer medications]] | [[Category:Esophageal cancer medications]] | ||
+ | [[Category:Esophageal squamous cell carcinoma medications]] | ||
[[Category:Hepatocellular carcinoma medications]] | [[Category:Hepatocellular carcinoma medications]] | ||
[[Category:Classical Hodgkin lymphoma medications]] | [[Category:Classical Hodgkin lymphoma medications]] | ||
+ | [[Category:Malignant solid neoplasm, MSI-H or dMMR medications]] | ||
[[Category:Nasopharyngeal carcinoma medications]] | [[Category:Nasopharyngeal carcinoma medications]] | ||
[[Category:Non-small cell lung cancer medications]] | [[Category:Non-small cell lung cancer medications]] | ||
[[Category:Non-small cell lung cancer, nonsquamous medications]] | [[Category:Non-small cell lung cancer, nonsquamous medications]] | ||
[[Category:Non-small cell lung cancer, squamous medications]] | [[Category:Non-small cell lung cancer, squamous medications]] | ||
− | [[Category:NMPA approved | + | [[Category:Urothelial carcinoma medications]] |
+ | |||
+ | [[Category:NMPA approved in 2019]] | ||
+ | [[Category:EMA approved in 2023]] |
Latest revision as of 01:19, 7 November 2023
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
- 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
Categories:
- Drugs
- Intravenous medications
- Anti-PD-1 antibodies
- Esophageal cancer medications
- Esophageal squamous cell carcinoma medications
- Hepatocellular carcinoma medications
- Classical Hodgkin lymphoma medications
- Malignant solid neoplasm, MSI-H or dMMR medications
- Nasopharyngeal carcinoma medications
- Non-small cell lung cancer medications
- Non-small cell lung cancer, nonsquamous medications
- Non-small cell lung cancer, squamous medications
- Urothelial carcinoma medications
- NMPA approved in 2019
- EMA approved in 2023