Table 2.
Therapeutic monoclonal antibodies for cancer therapy currently marketed with regulatory approval from the U.S. FDA or EMA or both (as at December 2021).
| Monoclonal Antibody INN and Trade Name | Type of mAb | Target | Approved Indications |
|---|---|---|---|
| Rat-mouse chimera (-axomab) | |||
| Catumaxomab (Removab®) | Rat IgG2b/Mouse IgG2a bispecfic |
EpCAM/CD3 | Malignant ascites |
| Mouse (-omab) | |||
| Blinatumomab (Blincyto®) | Mouse scFvκ-H bispecific | CD19/CD3 epsilon | Philadelphia chromosome-negative relapsed or refractory B cell precursor acute lymphoblastic leukemia |
| Ibritumomab tiuxetan (Zevalin®) |
Mouse IgG1 | CD20 | Non-HL |
| Moxetumomab pasudox– tdfk (Lumoxiti®) |
ADC immunotoxin. Mouse single chain variable domain (scFv) |
CD22 | HCL |
|
Human-mouse chimeric
(-ximab) |
|||
| Brentuximab vedotin (Adcetris®) |
Chimeric IgG1 | CD30 | HL after failure of stem cell transplant or chemotherapy; sALCL after failure of chemotherapy; post auto-HSCT consolidation treatment for HL |
| Cetuximab (Erbitux®) | Chimeric IgG1 | EFGR | Colorectal and head and neck cancers |
| Dinutuximab (Unituxin®) | Chimeric IgG1 | GD2 | Pediatric patients with high-risk neuroblastoma |
| Isatuximab-irfc (Sarclisa®) | Chimeric IgG1 with 2 identical H and κ L chains |
CD38 | MM |
| Margetuximab-cmkb (Margenza®) |
Chimeric IgG1 | HER2 | HER2-positive breast cancer |
| Rituximab (Rituxan®; MabThera®) |
Chimeric IgG1 | CD20 | Non-HL; CLL; rheumatoid arthritis; Wegener’s granulomatosis; microscopic polyangiitis |
| Siltuximab (Sylvant®) | Chimeric IgG1 | IL-6 | Multicentric Castelman’s disease in patients negative for HIV and HHV-8 |
| Humanized (-zumab) | |||
| Ado-trastuzumab emtansine (Kadcyla®) | ADC. Humanized IgG1 | HER2 | HER2-positive breast cancer in patients who previously received trastuzumab or a taxane |
| Alemtuzumab (Campath®; MabCampath®) |
Humanized IgG1 | CD52 | Campath, MabCampath: B cell CLL |
| Atezolizumab (Tecentriq®) | Humanised IgG1 | PD-L1 | MUC; NSCLC |
| Bevacizumab (Avastin®) | Humanized IgG1 | VEGF-A | Metastatic colorectal cancer; non-squamous NSCLC; metastatic breast cancer; ovarian cancer; glioblastoma |
| Dostarlimab-gxly (Jemperli®) | Humanized IgG4 | PD-1 | Endometrial cancer |
| Elotuzumab (Empliciti®) | Humanised IgG1 | SLAMF7 | MM |
| Fam-trastuzumab deruxtecan-nxki (Enhertu®) |
ADC. Humanised IgG1 | HER2 | HER2-positive breast, gastric, and GE adenocarcinomas |
| Gemtuzumab ozogamicin (Mylotarg®) |
ADC. Humanized IgG4 | CD33 | AML |
| Inotuzumab ozogamicin (Besponsa®) |
ADC. Humanized IgG4 | CD22 | ALL |
| Loncastumab tesirine-lpyl (Zynlonta®) |
ADC. Humanized IgG1 | CD19 with teserine cytotoxic agent |
LBCL including DLBCL |
| Mogamulizumab-kpkc (Poteligeo®) |
Humanized IgG1 | CCR4 | Mycosis fungoides; Sézary syndrome |
| Naxitamab-gqgk (Danyelza®) |
Humanized IgG1 | GD2 | Neuroblastoma—antibody given in combination with GM-CSF |
| Obinutuzumab (Gazyva®; Gazyvaro®) |
Humanized IgG1 | CD20 | In combination with chlorambucil for previously untreated CLL |
| Pembrolizumab (Keytruda®) | Humanized IgG4 | PD-1 | Unresectable or metastatic melanoma; refractory metastatic NSCLC tumors that express PD-L1 |
| Pertuzumab (Perjeta®) | Humanized IgG1 | HER2 | Combination with trastuzumab and docetaxel for HER2-positive metastatic breast cancer |
| Polatuzumab vedotin-piiq (Polivy®) |
ADC. Humanized IgG1 | CD79b | Diffuse large B cell lymphoma |
| Sacituzumab govitecan-hziy (Trodelvy®) |
ADC. Humanized IgG1 | Trop-2 with topoisomerase inhibitor | mTNBC |
| Tafasitamab-cxix (Monjuvi®) | Humanized IgG1/2 with hybrid Fc-modified domain | CD19 | DLBCL |
| Trastuzumab (Herceptin®) | Humanized IgG1 | HER2 | Breast cancer overexpressing HER2, metastatic gastric or GE junction adenocarcinoma overexpressing HER2 |
| Fully human (-umab) | |||
| Amivantamab-vmjw (Rybrevant®) |
Bi-specific low fucose human IgG1-based antibody |
EGFR and c-MET receptors | NSCLC |
| Avelumab (Bavencio®) | Human IgG1 | PD-L1 | MCC; UC; RCC |
| Belantamab mafodoton-blmf (Blenrep®) |
ADC afucosylated IgG1 |
BCMA with MMAF microtubule inhibitor |
MM |
| Cemiplimab-rwlc (Libtayo®) | Human IgG4 | PD-1 | CSCC |
| Daratumumab (Darzalex®) | Human IgG1 | CD38 | MM |
| Denosumab (Prolia®; Xgeva®) |
Human IgG2 | RANKL | Bone loss. Prolia: for osteoporosis and to increase bone mass; Xgeva: for bone metastases from solid tumors and giant cell tumor of bone |
| Durvalumab (Imfinzi®) | Human IgG1 | PD-L1 | UC |
| Enfortumab-vedotin-ejfv (Padcev®) |
ADC human IgG1 | Nectin-4 with MMAE microtubule inhibitor |
UC |
| Ipilimumab (Yervoy®) | Human IgG1 | CTLA-4 | Metastatic melanoma |
| Necitumumab (Portrazza®) | Human IgG1 | EGFR | Squamous NSCLC |
| Nivolumab (OPDIVO®) | Human IgG4 | PD-1 | Unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600-positive, a BRAF inhibitor; NSCLC |
| Ofatumumab (Arzerra®) | Human IgG1 | CD20 | CLL refractory to fludarabine and alemtuzumab |
| Olaratumab (Lartruvo®) | Human IgG1 | PDGFR-α | Soft tissue sarcoma |
| Panitumumab (Vectibix®) | Human IgG2 | EGFR | Metastatic colorectal cancer |
| Ramucirumab (Cyramza®) | Human IgG1 | VEGFR2 | Gastric or GE junction adeno- carcinoma; metastatic NSCLC with docetaxel after platinum therapy; HCC; with FOLFIRI for metastatic colorectal cancer |
| Tisotumab vedotin-tftv (Tivdak®) |
ADC human IgG1 | TF with MMAE microtubule inhibitor |
Cervical cancer |
ADC—antibody drug conjugate; ALL—acute lymphoblastic leukemia; auto-HSCT—autologous hematopoietic stem cell transplantation; BRAF—proto-oncogene B-Raf; C5—complement component 5; CLL—chronic lymphocytic leukemia; CTLA-4—cytotoxic T lymphocyte-associated antigen 4 or CD152; CSCC—cutaneous squamous cell carcinoma; DLBCL—diffuse large B cell lymphoma; EGFR—epidermal growth factor receptor; EMA—European Medicines Agency; EpCAM—epithelial cell adhesion molecule; FDA—U.S. Food and Drug Administration; FOLFIRI—combination of folinic acid (leucovorin), fluorouracil, and irinotecan; GD2—glycolipid disialoganglioside on neuroblastoma, central nervous system, and peripheral nerve cells; GE—gastroesophageal; HCC—hepatocellular carcinoma; HCL—hairy cell leukemia; HER2—human epidermal growth factor receptor 2, also known as HER2/neu, ErbB2, CD340, p185, or EGFR2; HL—Hodgkin lymphoma; IPP—International Nonproprietary Name; LBCL—large B cell lymphoma; MCC—Merkel cell carcinoma; MM—multiple myeloma; MMAE—cytotoxic agent monomethyl auristatin E; MMAF—cytotoxic agent monomethyl auristatin F; mTNBC—metastatic triple-negative breast cancer; MUC—metastatic urothelial carcinoma; NSCLC—non-small cell lung cancer; PD-1—programmed cell death protein 1 or CD279; PD-L1—programmed cell death protein ligand 1; RANKL—receptor activator of nuclear factor kappa-B ligand (CD254), a member of the TNF cytokine family; RCC—renal cell carcinoma; sALCL—systemic anaplastic large cell lymphoma; teserine—also known as SG3249, a pyrrolobenzodiazepine dimer; TF—tissue factor, platelet tissue factor, factor III, CD142; Trop-2—trophoblast cell surface antigen-2; UC—urothelial carcinoma; VEGF—vascular endothelial growth factor (a subfamily of growth factors; includes VEGF-A); VEGFR2—vascular endothelial growth factor receptor 2, also known as KDR (kinase insert domain-containing receptor), FLK1 (fetal liver kinase 1), or CD309.