Besponsa
(inotuzumab ozogamicin)ApprovedAntibody–drug conjugate
Inotuzumab ozogamicin is used to treat a type of blood cancer called B-cell acute lymphoblastic leukemia (ALL). It works by delivering a toxic compound directly to cancer cells to destroy them.[2] Besponsa is currently approved and in use across 16 indications[4].[1]
Besponsa is one of 247 small molecule programs targeting Leukemia. It is currently in Approved.
16
Indications
55
Total Trials
25
Active Trials
246
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 16 indications
Competition
Competitive Landscape
350 competitors in Treatment
#DrugCompanyPhaseTrials
1Besponsa
WWyeth-Lederle Vaccines
Approved
Dexilant
TakedaPreclinical
Niclocide
BayerPreclinical
Alfenta
Jazz PharmaceuticalsPreclinical
Hivid
CConrado Roberto Hoffmann Filho
Preclinical
Valium
Akero TherapeuticsPreclinical
Barhemsys
Tibotec Pharmaceuticals, IrelandPreclinical
Norpramin
VValidus Pharmaceuticals
Preclinical
Lotemax
PPharmos
Preclinical
Aurlumyn
BBTG International Inc.
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Acute Lymphoblastic Leukemia11 trials
Show 8 more trials
Phase II Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of Acute Lymphoblastic Leukemia
Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT06427330·21 enrolled
Lymphoma9 trials
Show 6 more trials
Leukemia4 trials
B Acute Lymphoblastic Leukemia3 trials
Treatment2 trials
International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020)
Not yet recruiting·—·Phase 3·NCT07476729·750 enrolled
23 more indications
B-ALL2 trials
Venetoclax Plus Inotuzumab for B-ALL
Active, not recruiting·—·Phase 1·NCT05016947·23 enrolled
B-cell acute lymphoblastic leukemia2 trials
Blinatumomab1 trial
Relapsed/Refractory B-cell ALL1 trial
Chemotherapy1 trial
Acute Leukemia1 trial
Lymphoid Malignancies1 trial
Efficacy and Safety1 trial
Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Adult Ph- B-ALL
Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT06387121·53 enrolled
BOS1 trial
Non-Hodgkins Lymphoma1 trial
Combination Therapy1 trial
Minimal Residual Disease1 trial
Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy
Active, not recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT05456698·31 enrolled
Acute Lymphocytic Leukemia1 trial
Acute Myeloid Leukemia1 trial
Recurrent B Acute Lymphoblastic Leukemia1 trial
Ph+ ALL1 trial
Acute Lymphoid Leukemia1 trial
A Phase IIA Study of Feasibility and Effectiveness of Inotuzumab Ozogamicin (IO) in Adult Patients With B-Cell Acute Lymphoblastic Leukemia With Positive Minimal Residual Disease Before Any Hematopoietic Stem Cell Transplantation
Active, not recruiting·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT03610438·76 enrolled
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL11 trial
Regulatory
FDA Approval Timeline[5]
Aug 17, 2017
BESPONSA
BLA BLA761040
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Besponsa drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for inotuzumab ozogamicin. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
Details
Drug Info
Quick Facts
- Mechanism of Action
- CD22 Binding Agent[3]
- Modality
- Antibody–drug conjugate[3]
- Highest Phase
- Approved[1]
- Company
- WWyeth-Lederle Vaccines