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 96 indications[4].[1]
Beyfortus is one of 1257 small molecule programs targeting Prostate Cancer. It is currently in Approved.
96
Indications
414
Total Trials
104
Active Trials
1,256
Competitors
5
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 96 indications
Competition
Competitive Landscape
414 competitors in Non-Small Cell Lung Cancer
#DrugCompanyPhaseTrials
1Beyfortus
BeiGeneApproved
Zimberelimab
Arcus BiosciencesPhase 3
HD204
PPrestige Biopharma Limited
Phase 3
Remeron
OOrganon and Co
Preclinical
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
Treatment
GSKPreclinical
PD-1 Inhibitors
BBioNTech US Inc.
Preclinical
Valemetostat Tosylate
Daiichi SankyoPreclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Q4 2026
Phase 3Not yet recruiting
Non-Small Cell Lung Cancer
NCT05990127
Phase 1Recruiting
Tislelizumab
NCT06349837
Phase 2/3Recruiting
Locally-Advanced Rectal Cancer
NCT06312982
Phase 2Not yet recruiting
Colorectal Cancer
NCT06218888
Phase 2Recruiting
Radiation Therapy
NCT06379087
Phase 2Not yet recruiting
Chemotherapy
NCT06118658
Clinical
Trials by Indication[1]
Colorectal Cancer12 trials
LDRT Combined With Immunochemotherapy for Colorectal Cancer With Liver Metastasis
Recruiting·—·Phase 1·NCT06848465·9 enrolled
Show 9 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
"Thymalfasin Immunotherapy Study with Triple Regimen in Advanced MSS/pMMR Colorectal Cancer"
Recruiting·—·Phase 2·NCT06829355·52 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
LDRT Sequential NIPS Immunochemotherapy for Peritoneal Metastasis of Gastric and Colorectal Cancer
Not yet recruiting·—·Phase 1·NCT07453875·9 enrolled
Non-Small Cell Lung Cancer12 trials
Show 9 more trials
Tislelizumab12 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
Show 9 more trials
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
A Multicenter, Single-Arm, Open-Label, Phase II Trial of Mosunetuzumab in Combination With Tislelizumab for r/r FL
Not yet recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT07031700·22 enrolled
Hepatocellular Carcinoma11 trials
Show 8 more trials
Esophageal Squamous Cell Carcinoma9 trials
Show 6 more trials
Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma
Recruiting·—·Phase 1·NCT05984342·50 enrolled
76 more indications
Locally-advanced Rectal Cancer8 trials
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
A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer
Recruiting·—·Phase 2/3·NCT06312982·375 enrolled
Show 5 more trials
Lung Cancer7 trials
Show 4 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
Gastric Cancer7 trials
Show 4 more trials
Lymphoma6 trials
Show 3 more trials
Esophageal Cancer5 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
Solid Tumors4 trials
Bladder Cancer4 trials
Show 1 more trial
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
Chemotherapy3 trials
Neoadjuvant of Tislelizumab Combined With Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC
Unknown status·—·Phase 2·NCT05611879·30 enrolled
Chemotherapy Sequential Tislelizumab After Radical Resection in Patients With dMMR/MSI-H or POLE/POLD1 Mutations
Not yet recruiting·—·Phase 2·NCT06118658·30 enrolled
Metastatic Colorectal Cancer3 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
Nasopharyngeal Carcinoma3 trials
Advanced Solid Tumors3 trials
Adenocarcinoma3 trials
Efficacy and Safety3 trials
Pancreatic Cancer3 trials
Tislelizumab Combined With Nab-paclitaxel and Gemcitabine for Recurrent Pancreatic Cancer
Unknown status·—·Phase 2·NCT04902261·140 enrolled
Neoadjuvant Therapy3 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
Prostate Cancer2 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
Intrahepatic Cholangiocarcinoma2 trials
Maintenance Therapy2 trials
Melanoma2 trials
Triple-Negative Breast Cancer2 trials
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
Neoadjuvant Chemotherapy2 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
Squamous Cell Carcinoma2 trials
Patients With Advanced Solid Tumors2 trials
Conversion Therapy2 trials
Unresectable2 trials
Other Solid Tumors2 trials
Uveal Melanoma1 trial
Breast Cancer1 trial
Study of Tislelizumab Plus Chemotherapy vs Chemotherapy as Perioperative Treatment in Participants With HER2 Negative Breast Cancer
Unknown status·—·Phase 2·NCT04498793·55 enrolled
Liver Cancer1 trial
Advanced Malignancies1 trial
B-cell Malignancies1 trial
Advanced or Metastatic Solid Tumors1 trial
Treatment1 trial
Liver Metastases1 trial
Malignant Tumors1 trial
Metastasis1 trial
Phase II Clinical Study1 trial
Locally Advanced1 trial
Monoclonal1 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
Brentuximab Vedotin1 trial
Phase II Clinical Trial1 trial
Radiation Therapy1 trial
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
HER2 Positive1 trial
Neoadjuvant Immunotherapy1 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
Endometrial Cancer1 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
Safety and Efficacy1 trial
Prospective1 trial
A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After NAC in TNBC
Recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2·NCT04501523·460 enrolled
Ovarian Cancer1 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]