Beyfortus
(Tislelizumab)ApprovedMonoclonal antibody
BeiGeneTislelizumab is used to treat certain types of lymphoma (blood cancers) by helping the immune system recognize and destroy cancer cells.[2] Beyfortus is currently approved and in use across 105 indications[4].[1]
Beyfortus is one of 1287 small molecule programs targeting Prostate Cancer. It is currently in Approved.
105
Indications
405
Total Trials
103
Active Trials
1,286
Competitors
5
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 105 indications
Competition
Competitive Landscape
449 competitors in Non-Small Cell Lung Cancer
#DrugCompanyPhaseTrials
1Beyfortus
BeiGeneApproved
Cytoxan
BBaxter Healthcare Corporation
Phase 3
Zolinza
CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Phase 3
Remeron
OOrganon and Co
Preclinical
Treatment
GSKPreclinical
Valemetostat Tosylate
Daiichi SankyoPreclinical
Aqupla
Jiangsu Simcere Pharmaceutical Co., Ltd.Preclinical
Ftorafur
TThe First Affiliated Hospital with Nanjing Medical University
Preclinical
Vibramycin
PPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Preclinical
PD-1 Inhibitors
BBioNTech US Inc.
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Q4 2026
Phase 2Not yet recruiting
Non-Small Cell Lung Cancer
NCT06883552
Phase 2Recruiting
Head Neck Cancer
NCT05595590
Phase 3Not yet recruiting
Non-Small Cell Lung Cancer
NCT05990127
Phase 1Recruiting
Tislelizumab
NCT06349837
Phase 2Not yet recruiting
Colorectal Cancer
NCT06218888
Phase 2/3Recruiting
Locally-Advanced Rectal Cancer
NCT06312982
Clinical
Trials by Indication[1]
Non-Small Cell Lung Cancer12 trials
Show 9 more trials
Hepatocellular Carcinoma12 trials
Show 9 more trials
Tislelizumab Monotherapy or Combined With Lenvatinib as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma.
Unknown status·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT05807776·50 enrolled
Colorectal Cancer11 trials
LDRT Combined With Immunochemotherapy for Colorectal Cancer With Liver Metastasis
Recruiting·—·Phase 1·NCT06848465·9 enrolled
Show 8 more trials
Disitamab Vedotin Combined With Tislelizumab in Advanced HER2 Positive Colorectal Cancer
Unknown status·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT05493683·29 enrolled
Futibatinib in Combination With (Chemo)Immunotherapy in Colorectal Cancer and Other Solid Tumor Entities
Recruiting·IInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest·Phase 2·NCT06722183·33 enrolled
"Thymalfasin Immunotherapy Study with Triple Regimen in Advanced MSS/pMMR Colorectal Cancer"
Recruiting·—·Phase 2·NCT06829355·52 enrolled
Esophageal Squamous Cell Carcinoma11 trials
Show 8 more trials
Circulating Tumor DNA MRD-Guided Adjuvant Therapy for Curatively Resected Locally Advanced Esophageal Squamous Cell Carcinoma
Not yet recruiting·—·Phase 3·NCT06914011·172 enrolled
Tislelizumab11 trials
Phase II Study of Moderate-dose Hypofractionated RT Combined With Tislelizumab for HCC With Diffuse Tumor Thrombosis
Unknown status·—·Phase 2·NCT06233981·30 enrolled
Propranolol With Tislelizumab Plus GC in Neoadjuvant Bladder UC
Not yet recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 1·NCT07353294·12 enrolled
Show 8 more trials
81 more indications
Lung Cancer8 trials
Show 5 more trials
Study of Chemotherapy and PD-1 Inhibitor Combination With Anti-angiogenesis to Treat Elderly Lung Cancer
Unknown status·TTianjin Medical University Cancer Institute and Hospital·Phase 1·NCT05273814·30 enrolled
LK101 Combined With PD-1 or PD-L1 Monoclonal Antibody in the Treatment of Lung Cancer
Recruiting·—·Phase 1/2·NCT05886439·60 enrolled
Esophageal Cancer6 trials
Chemoradiotherapy Plus Immunotherapy Followed by Surgery for Esophageal Cancer
Active, not recruiting·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 2·NCT04776590·30 enrolled
Show 3 more trials
Locally-advanced Rectal Cancer5 trials
Show 2 more trials
A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer
Recruiting·—·Phase 2/3·NCT06312982·375 enrolled
Neoadjuvant Arterial Embolization Chemotherapy Combined PD-1 Inhibitor for Locally Advanced Rectal Cancer
Unknown status·TThe Fourth Affiliated Hospital of Zhejiang University School of Medicine·Phase 2·NCT05420584·83 enrolled
Lymphoma5 trials
Gastric Cancer5 trials
Maintenance Therapy4 trials
Pancreatic Cancer4 trials
Tislelizumab Combined With Nab-paclitaxel and Gemcitabine for Recurrent Pancreatic Cancer
Unknown status·—·Phase 2·NCT04902261·140 enrolled
Show 1 more trial
Bladder Cancer4 trials
Advanced Solid Tumors3 trials
Efficacy and Safety3 trials
Nasopharyngeal Carcinoma3 trials
Small Cell Lung Cancer3 trials
Prospective, Single-arm, Phase II Clinical Study of Irinotecan Hydrochloride Liposome Injection Combined With Platinum and Immune Checkpoint Inhibitors Combined With Anlotinib for the Maintenance of Extensive Small Cell Lung Cancer After First-line Induction
Not yet recruiting·—·Phase 4·NCT06951841·31 enrolled
Solid Tumors3 trials
Prostate Cancer3 trials
First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer
Active, not recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT05189457·32 enrolled
Triple-Negative Breast Cancer2 trials
Metastatic Colorectal Cancer2 trials
- IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Cancer Without Active Liver Metastases
Recruiting·IInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest·Phase 2·NCT06856837·140 enrolled
Squamous Cell Carcinoma2 trials
Cervical Cancer2 trials
Tislelizumab Combined With Concurrent Chemoradiotherapy as First-line Treatment for Stage IIIC2 Cervical Cancer
Recruiting·FFirst Affiliated Hospital of Guangxi Medical University·Phase 2·NCT05511623·112 enrolled
Locally Advanced2 trials
Breast Cancer2 trials
Study of Tislelizumab Plus Chemotherapy vs Chemotherapy as Perioperative Treatment in Participants With HER2 Negative Breast Cancer
Unknown status·—·Phase 2·NCT04498793·55 enrolled
Neoadjuvant Therapy2 trials
Tirelizumab in Combination With Carboplatin and Polymeric Micellar Paclitaxel for Neoadjuvant Therapy in cN+ HNSCC
Not yet recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2·NCT06366945·85 enrolled
Adjuvant Therapy2 trials
A Phase II Study of Tislelizumab as Adjuvant Therapy for Patients With Stage Ⅱ and Stage Ⅲ Colon Cancer and dMMR/MSI.
Not yet recruiting·TThe First Affiliated Hospital of Zhengzhou University·Phase 2·NCT05231850·70 enrolled
Adenocarcinoma2 trials
Chemotherapy2 trials
Chemotherapy Sequential Tislelizumab After Radical Resection in Patients With dMMR/MSI-H or POLE/POLD1 Mutations
Not yet recruiting·—·Phase 2·NCT06118658·30 enrolled
Neoadjuvant of Tislelizumab Combined With Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC
Unknown status·—·Phase 2·NCT05611879·30 enrolled
Conversion Therapy2 trials
Head and Neck Squamous Cell Carcinoma2 trials
A Multicenter Phase II Trial of Post-operative Concurrent Chemoradiotherapy Using Weekly Cisplatin With Tislelizumab for Patients With High-risk Head and Neck Squamous Cell Carcinoma：The POTENTIAL Study
Unknown status·SShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University·Phase 2·NCT04814069·38 enrolled
Treatment2 trials
Combination Therapy2 trials
Unresectable2 trials
Head Neck Cancer1 trial
Radiotherapy With Tislelizumab in Patients With Recurrent Head & Neck Cancer
Recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT05595590·20 enrolled
Advanced1 trial
Central Nervous System Lymphoma1 trial
Nab-paclitaxel1 trial
Advanced Solid Tumor1 trial
Radiotherapy1 trial
Biliary Tract Tumors1 trial
Monoclonal1 trial
Intrahepatic Cholangiocarcinoma1 trial
Lung Adenocarcinoma1 trial
Chemoradiotherapy1 trial
Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer
Active, not recruiting·—·Phase 2·NCT06056804·20 enrolled
HER2 Positive1 trial
Neoadjuvant Immunotherapy1 trial
Patients With Advanced Solid Tumors1 trial
Anti-PD-1 Antibody1 trial
Anti-PD-1 Antibody Combined With Autologous DC and NK Cells in the Treatment of Digestive Carcinoma
Unknown status·—·Phase 2·NCT05461235·1 enrolled
Organ Preservation1 trial
PD-1 Inhibitor1 trial
Metastatic Nasopharyngeal Cancer1 trial
Liver Metastases1 trial
Advanced Malignancies1 trial
Uveal Melanoma1 trial
Other Solid Tumors1 trial
Elderly Patients1 trial
Combined Inhibition of PD-1 and DNA Hypomethylating Agent +/- Chemotherapy in High-risk AML or Elderly Patients With AML Who Are Unfit for Intensive Chemotherapy
Unknown status·—·Phase 2·NCT04541277·55 enrolled
Adjuvant Treatment1 trial
Glioblastoma1 trial
TTField in Combination With Temozolomide and Tislelizumab in The Treatment of Newly Diagnosed Glioblastoma.
Recruiting·JJiangsu Healthy Life Innovation Medical Technology Co., Ltd·Phase 2·NCT06353360·30 enrolled
Targeted Therapy1 trial
Locally Advanced or Metastatic Solid Tumors1 trial
Endometrial Cancer1 trial
Pancreatic Ductal Adenocarcinoma1 trial
B-cell Malignancies1 trial
Metastasis1 trial
First-line Treatment1 trial
Tislelizumab Combined With Chemotherapy in First-line Treatment of AGC
Unknown status·—··NCT06034964·60 enrolled
Diffuse Large B-Cell Lymphoma1 trial
Advanced Biliary Tract Carcinoma1 trial
Multiple Cancer1 trial
Phase II Clinical Trial1 trial
Phase II Clinical Study1 trial
Malignant Tumors1 trial
Radiation Therapy1 trial
Brentuximab Vedotin1 trial
Pancreatic Adenocarcinoma1 trial
Melanoma1 trial
Regulatory
FDA Approval Timeline[5]
Jul 17, 2023
BEYFORTUS
NDA BLA761328
Feb 23, 2024
BEYFORTUS
NDA BLA761328
Aug 22, 2024
BEYFORTUS
NDA BLA761328
Oct 20, 2025
BEYFORTUS
NDA BLA761328
Apr 7, 2026
BEYFORTUS
NDA BLA761328
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Beyfortus drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Tislelizumab. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]