Overview
Tislelizumab is under investigation in clinical trial NCT02660034 (The Safety, Pharmacokinetics and Antitumor Activity of BGB-A317 in Combination With BGB-290 in Subjects With Advanced Solid Tumors).
Indication
⑴用于治疗至少经过二线系统化疗的复发或难治性经典型霍奇金淋巴瘤（R/R cHL）患者。 ⑵用于治疗局部晚期或转移性尿路上皮癌。 ⑶联合化疗用于治疗一线晚期非鳞状非小细胞肺癌（NSCLC）患者。 ⑷用于治疗既往接受过治疗的不可切除肝细胞癌患者。 ⑸用于治疗晚期恶性实体瘤
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/22 | Not Applicable | Not yet recruiting | |||
2025/08/20 | Not Applicable | Not yet recruiting | First Affiliated Hospital of Guangxi Medical University | ||
2025/08/17 | Not Applicable | Recruiting | Tianjin Medical University Second Hospital | ||
2025/08/07 | Not Applicable | Recruiting | |||
2025/08/01 | Not Applicable | Not yet recruiting | |||
2025/07/25 | Not Applicable | Recruiting | Sun Yat-sen University | ||
2025/07/22 | Not Applicable | Not yet recruiting | |||
2025/07/16 | Not Applicable | Not yet recruiting | Xiangdong Cheng | ||
2025/07/16 | Not Applicable | Not yet recruiting | |||
2025/07/10 | Not Applicable | Not yet recruiting | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| BEIGENE USA, INC. | 72579-121 | INTRAVENOUS | 10 mg in 1 mL | 3/16/2024 | |
| BeOne Medicines USA, Inc. | 72579-121 | INTRAVENOUS | 10 mg in 1 mL | 3/16/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/15/2023 | ||
Authorised | 9/15/2023 | ||
Authorised | 9/15/2023 | ||
Withdrawn | 4/19/2024 | ||
Authorised | 9/15/2023 | ||
Authorised | 9/15/2023 | ||
Authorised | 9/15/2023 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| TEVIMBRA CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/10ML | SIN17089P | INFUSION, SOLUTION CONCENTRATE | 100mg/10mL | 9/19/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| TEVIMBRA CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG/10 ML | N/A | N/A | N/A | 10/14/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| TEVIMBRA tislelizumab 100 mg/10 mL concentrated injection vial | 391176 | Medicine | A | 5/30/2024 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| TEVIMBRA 100 MG CONCENTRADO PARA SOLUCION PARA PERFUSION | Beigene Ireland Limited | 1231758001 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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