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Approved Monoclonal Antibodies for Cancer Treatment

Worldwide Approved Oncology Targeting Monoclonal Antibodies & Antibody Drug Conjugates

May 30, 2022
in Antibodies, Antibody Drug Conjugate, Bispecific Antibody, Monoclonal Antibodies, Oncology
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In 1986, muromonab-CD3 (OKT3) wins the first therapeutic monoclonal antibody approval from the US FDA, which works as an immunosuppressive for the prevention of transplant rejection.

Global Oncology Intelligence Global Oncology Intelligence

Since from past more than three decades from the first approval, till now more than 100 antibodies are approved by US FDA, which includes largest 42 approvals for cancer treatment itself. Beside this there are 8 other cancer targeting antibodies, which were approved by other health agencies but not by US FDA.

In 2020, antibodies accounted for 9 of the Top 20 Therapeutics by sales, with cumulative earnings of US$62 billion that year, with half of this sales coming from Cancer targeting four key antibodies.

Similarly, from past two decade we saw a continue rise in antibody drug discovery, with now nearly

Read Also –

 

Approved Cancer Targeting  Monoclonal Antibodies between 2021-2016

Sl No. Name Brand name  Marketing Company  Target Format  First  approval year  Oncology Approved Indications
49 Amivantamab-vmjw Rybrevant Janssen Pharmaceuticals, Inc. EGFR, cMET Human bispecific IgG1 2021 In May 2021, FDA Approves Rybrevant as the First Targeted Treatment for Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.
48 Loncastuximab tesirine-lpyl Zynlonta ADC Therapeutics SA CD19 Humanized IgG1 ADC 2021 In April 2021, FDA approved Zynlonta, a CD19-directed ADC, for the treatment of adult patients with relapsed or refractory large B-cell lymphoma.
47 Dostarlimab, dostarlimab-gxly Jemperli GlaxoSmithKline PD-1 Humanized IgG4 2021 In April 2021, FDA approved Jemperli, a programmed death receptor-1 (PD-1)–blocking antibody for the treatment of women with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer.
46 Margetuximab-cmkb Margenza  MacroGenics, Inc. HER2 Chimeric IgG1 2020 In Dec 2020, US FDA approved Margenz, a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2+ breast cancer.
45 Naxitamab-gqgk Danyelza Y-mAbs Therapeutics, Inc. GD2 Humanized IgG1 2020 In Nov 2020, Danyelza, a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GMCSF), for the treatment of patients with relapsed or refractory high-risk neuroblastoma. High-risk neuroblastoma and refractory osteomedullary disease
44 Prolgolimab** Forteca PD-1 Humanized IgG2 2020 Prolgolimab is an anti-PD-1 mAb approved in Russia in 2020 for melanoma. 
43 Belantamab  mafodotin-blmf Blenrep GlaxoSmithKline B-cell maturation antigen Humanized IgG1 ADC 2020 In August 2020, US FDA approves Blenrep, a B-cell maturation antigen (BCMA)-directed antibody drug conjugate indicated for the treatment of adult patients with relapsed or refractory multiple myeloma.
42 Tafasitamab-cxix Monjuvi MorphoSys AG CD19 Humanized IgG1 2020 In July 2020, US FDA approves Monjuvi, a CD19-directed cytolytic antibody indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
41 Sacituzumab  govitecan-hziy Trodelvy Immunomedics, Inc. TROP-2 Humanized IgG1 ADC 2020 In April 2020, US FDA approves Trodelvy, a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of metastatic triple-negative breast cancer (mTNBC) and metastatic urothelial cancer (mUC).
40 Isatuximab, isatuximab-irfc Sarclisa Sanofi CD38 Chimeric IgG1 2020 In Mar 2020, FDA Approves Sarclisa, a CD38-directed cytolytic antibody for patients with Relapsed Refractory Multiple Myeloma.
39 Tislelizumab**   BeiGene / Novartis PD-1 Human mAb IgG4 2019 In Dec 2019, Tislelizumab was approved by China's National Medical Products Administration for the treat patients with classical Hodgkin’s lymphoma (cHL) who have received at least two prior therapies. Later in 2020, Tislelizuma was approved for the treatment of advanced non-small cell lung cancer (NSCLC) in China.
38 Camrelizumab** AiRuiKa Jiangsu Hengrui Medicine PD-1 Human mAb IgG4 2019 In Feb 2019, Camrelizumab (AiRuiKa™) a programmed cell death 1 (PD-1) inhibitor received conditional approval in China for the treatment of relapsed or refractory classical Hodgkin lymphoma.
37 Enfortumab  vedotin-ejfv Padcev Astellas,  Seattle Genetics Nectin-4 Human IgG1 ADC 2019 In Dec 2019, US FDA approved Padcev, a Nectin-4 targeted antibody-drug conjugate (ADC) for the treatment of patients with locally advanced or metastatic urothelial cancer.
36 fam-trastuzumab deruxtecan-nxki Enhertu AstraZeneca, Daiichi Sankyo HER2 Humanized IgG1 ADC 2019 In Dec 2019, FDA approves, Enhertu, a HER2-directed antibody and topoisomerase inhibitor conjugate for the treatment of adult patients with unresectable or metastatic HER2+ breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting; and adult patients with locally advanced or metastatic HER2+ gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.
35 Polatuzumab  vedotin-piiq Polivy Roche / Genentech, Inc. CD79b Humanized IgG1 ADC 2019 In June 2019, US FDA approved Polivy, a CD79b-directed antibody–drug conjugate, in combination with bendamustine and rituximab for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, who have received at least two prior therapies.
34 Sintilimab** Tyvyt Lilly, Innovent PD-1 Human mAb IgG4 2018 Sintilimab is a human IgG4 anti-PD-1 mAb approved in China in December 2018 for the relapsed or refractory classic Hodgkin's lymphoma after at least two lines of systemic chemotherapy.
33 Toripalimab** Tuoyi TopAlliance Biosciences, Inc. PD-1 Human mAb IgG4 2018 In Dec 2018, Tuoyi, a humanized anti-PD-1 mAb was approved in China for the treatment of Melanoma. 
32 Cemiplimab-rwlc Libtayo Regeneron PD-L1 Human mAb IgG4 2018 In Sep 2018, FDA approved Libtayo for Advanced Cutaneous Squamous Cell Carcinoma. Later in 2021, approved for Advanced Basal Cell Carcinoma and with First-line Advanced Non-Small Cell Lung Cancer with PD-L1 Expression of ≥50%.
31 Moxetumomab  pasudotox-tdfk Lumoxiti AstraZeneca CD22 Murine IgG1 dsFv immunotoxin 2018 In Sep 2018, FDA approved Lumoxiti, an anti-CD22 recombinant immunotoxin for the treatment of adult patients with hairy cell leukemia.
30 Inotuzumab ozogamicin  Besponsa Pfizer Inc. CD22 Humanized IgG4; ADC  2017 In Aug 2017, US FDA approved Besponsa, a CD22 monoclonal antibody and calicheamicin cytotoxic agent conjugate for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
29 Avelumab  Bavencio  EMD Serono, Inc. / Pfizer PD-L1 Human IgG1  2017 In MAr 2017, US FDA approved Bavencio, a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of patients with metastatic Merkel cell carcinoma (MCC) and later for the treatment of patients with advanced or metastatic urothelial carcinoma; and in combination with axitinib for patients with advanced renal cell carcinoma.
28 Durvalumab  Imfinzi Astrazeneca PD-L1 Human IgG1  2017 In May 2017, Imfinzi received FDA accelerated approval for previously treated patients with Advanced Bladder Cancer. And later for Advance Non-Small Cell Lung Cancer, Small Cell Lung Cancer.
27 Olaratumab  Lartruvo  Eli Lilly PDGFRα Human IgG1  2016 Olaratumab was granted accelerated approval (as Lartruvo) as initial therapy to treat adults with certain types of soft tissue sarcoma (STS) in October, 2016.
26 Atezolizumab  Tecentriq  Roche PD-L1 Humanized IgG1  2016 Tecentriq (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody, first approved in May 2016, for the treatment of Urothelial Carcinoma. Later drug was approved for the treatment of non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), small cell lung cancer (SCLC), heptatocellular carcinoma and melanoma.  

Approved Cancer Targeting  Monoclonal Antibodies between 2015-1995

Sl No. Name Brand name  Marketing Company  Target Format  First  approval year  Oncology Approved Indications
25 Necitumumab  Portrazza  Eli Lilly and Company EGFR Human IgG1  2015 In Nov 2015, US FDA approves Portrazza (necitumumab) for Advanced Squamous Non-Small Cell Lung Cancer 
24 Elotuzumab  Empliciti  Bristol-Myers Squibb, AbbVie SLAMF7 Humanized IgG1  2015 Elotuzumab is a Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory antibody, approved by FDA in Nov 2015 for the combination treatment of patients with multiple myeloma.
23 Daratumumab   Darzalex Janssen Biotech, Inc. CD38 Human IgG1  2015 Daratumumab is a human anti-CD38 monoclonal antibody indicated for the treatment of patients with multiple myeloma.
22 Dinutuximab  Qarziba; Unituxin  United Therapeutics GD2 Chimeric IgG1  2015 Unituxin (dinutuximab) is a chimeric monoclonal antibody used for the treatment of pediatric neuroblastoma.
21 Blinatumomab   Blincyto Amgen CD19, CD3 Murine bispecific tandem scFv  2014 blinatumomab is a bispecific CD19-directed CD3 T-cell engager approved on Dec 2014 by US FDA  for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), and minimal residual disease (MRD)-positive B-cell precursor ALL.
20 Nivolumab  Opdivo  Bristol Myers Squibb / Celgene  PD1 Human IgG4  2014 In Dec 2014, FDA approves Opdivo (nivolumab) for Advanced Melanoma Melanoma. Since its first approval FDA approved Opdivo for the treatment of Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Hodgkin's Lymphoma, Head and Neck Cancer, Urothelial Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Esophageal Carcinoma, Malignant Pleural Mesothelioma, Gastric Cancer.
19 Pembrolizumab  Keytruda  Merck & Co. PD1 Humanized IgG4  2014 Pembrolizumab was first approved in  Sep 2014 for Advanced Melanoma. Later the drug is also approved for the treatment of non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, endometrial carcinoma, tumor mutational burden-high (TMB-H) cancer, cutaneous squamous cell carcinoma, and triple-negative breast cancer. 
18 Ramucirumab  Cyramza  Eli Lilly VEGFR2 Human IgG1  2014 In Apr 2014, US FDA approves Cyramza for Stomach Cancer. Later it approves drug for the use in  Non-Small Cell Lung Cancer, Colorectal Cancer, Hepatocellular Carcinoma.
17 Obinutuzumab  Gazyva, Gazyvaro  Roche CD20 Humanized IgG1 Glycoengineered  2013 In Nov 2013, FDA Approves Gazyva for Chronic Lymphocytic Leukemia. Later in 2016 for Advance Follicular Lymphoma.
16 Ado-trastuzumab emtansine    Kadcyla Roche HER2 humanized IgG1; ADC 2013 In Feb 2013, FDA approved Kadcyla for Late-Stage Breast Cancer.
15 Pertuzumab  Perjeta  Roche HER2 humanized IgG1  2012 In Jun 2012, US FDA first approves Perjeta (pertuzumab) for People With HER2-Positive Metastatic Breast Cancer. 
14 mogamulizumab-kpkc Poteligeo Kyowa Kirin CCR4 Human IgG2 2012 Mogamulizumab was approved in Japan in 2012, for the treatment of relapsed or refractory CCR4+ adult T-cell leukemia/lymphoma and in 2014, for relapsed or refractory CCR4+ cutaneous T cell lymphoma. In Aug 2018  US FDA approve it for treatment of relapsed or refractory mycosis fungoides and Sézary disease, the most common subtypes of cutaneous T-cell lymphoma (CTCL).
13 Brentuximab vedotin  Adcetris Takeda / Seagen  CD30 Chimeric IgG1; ADC  2011 In Aug 2011, US FDA approved Adcetris (brentuximab vedotin) for the treatment of Hodgkin lymphoma (HL) and a rare lymphoma known as systemic anaplastic large cell lymphoma (ALCL).
12 Ipilimumab  Yervoy  BMS/Celgene CTLA-4 Human IgG1  2011 In Mar 2011, US FDA first approves Yervoy for the treatment of Late-Stage Melanoma. Later it was also approved for the treatment of Renal Cell Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Non-Small Cell Lung Cancer, Malignant Pleural Mesothelioma
11 Ofatumumab  Arzerra  Glaxo SmithKline CD20 Human IgG1  2009 In Oct 2009, US FDA approves Ofatumumab for Chronic Lymphocytic Leukemia.
10 Panitumumab  Vectibix  Amgen EGFR Human IgG2  2006 In Sep 2006, FDA Approves panitumumab to treat Patients with Metastatic Colorectal Cancer. Later drug was approved for treatment of Colorectal Cancer, Non-Small Cell Lung Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Cervical Cancer, Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Hepatocellular Carcinoma
9 Cetuximab  Erbitux   Eli Lilly /BMS/ Merck KGaA EGFR Chimeric IgG1  2004 Cetuximab was approved by FDA in Feb 2004 to Treat Irinotecan Refractory or Intolerant Metastatic Colorectal Cancer. Later in 2011, FDA Approves Erbitux to Treat Late-stage Head and Neck Cancer.
8 Bevacizumab  Avastin  Roche VEGF Humanized IgG1  2004 Bevacizumab was first approved in 2004 for the treatment for Metastatic Colorectal Cancer. In 
7 Tositumomab-I131  Bexxar  Glaxo SmithKline CD20 Murine IgG2a  2003 131 I-Tositumomab is a radiolabeled anti-CD20 antibody approved in US in 2003, for the treatment of non-Hodgkin lymphoma (NHL). Bexxar has been approved in Canada since 2005.
6 Ibritumomab tiuxetan  Zevalin  Biogen Idec CD20 Murine IgG1  2002 ibritumomab tiuxetan was the first radioimmunotherapy drug approved by the FDA in 2002, for the treatment of patients with relapsed or refractory, low‑grade or follicular B‑cell non‑Hodgkin's lymphoma (NHL), including patients with rituximab refractory follicular NHL.
5 Alemtuzumab  Lemtrada; MabCampath, Campath-1H    CD52 Human IgG1  2001 Alemtuzumab, sold under the brand names Campath and Lemtrada was approved in 2001 for chronic lymphocytic leukemia and in 2013 for multiple sclerosis.
4 Gemtuzumab ozogamicin  Mylotarg  Pfizer Inc. CD33 Humanized IgG4; ADC  2000 Gemtuzumab ozogamicin was the first antibody-drug conjugate to be approved for the treatment of Acute myeloid leukemia. In June 2010, Pfizer withdrew Mylotarg from the market at the request of the US FDA, but in In 2017, Pfizer reapplied for approval, based on new clinical findings. In Sep 2017, gemtuzumab ozogamicin was re-approved again for use in the United States and in the European Union. 
3 Trastuzumab  Herceptin  Roche HER2 Humanized IgG1  1998 In 1998, Herceptin was first approved for HER2+ Breast cancer. Later in Oct 2010, for HER2 + Metastatic Stomach Cancer
2 Rituximab  MabThera, Rituxan  Roche CD20 Chimeric IgG1  1997 Non-Hodgkin lymphoma 
1 Edrecolomab  Panorex    EpCAM Murine IgG2a  1995 Edrecolomab has been approved in Europe (Germany) for resected stage III colorectal cancer treatment, since 1995 to date has not been approved by the FDA. 
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