Approved Monoclonal Antibodies for Cancer Treatment

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.

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

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.