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Previous Issues Volume 7, Issue 1 - 2023
FDA Approved Anti-HER2 Therapy for HER+ Cancer
Henry Hongrong Cai, MD* and Ayesha A Pandit, MD MS
Premier Research, 3800 Paramount Parkway, Morrisville, NC 27560, USA
*Corresponding author: Henry Hongrong Cai, MD, Premier Research, 3800 Paramount Parkway, Morrisville, NC 27560, USA, Tel +1 252 230 6449; Emails: [email protected]; [email protected].
Received Date: December 12, 2022
Published Date: January 04, 2023
Citation: Cai HH and Pandit AA. (2023). FDA Approved Anti-HER2 Therapy for HER+ Cancer. Mathews J Immunol Allergy. 7(1):16.
Copyrights: Cai HH and Pandit AA. © (2023).
MINI-REVIEW
According to US national Breast Cancer Foundation, 1 in 8 women in the United States will develop breast cancer in her lifetime. In 2020, an estimated 276,480 new cases of invasive breast cancer will be diagnosed in women in the U.S. as well as 48,530 new cases of non-invasive (in situ) breast cancer. 81% of breast cancer diagnoses in the United States are invasive. 20% of invasive breast cancers are found to have human epidermal growth factor receptor 2 (HER2) protein overexpression and/or HER2 gene amplification. HER2 was selected as target to develop monoclonal antibody therapy for HER2+ breast cancer and other HER2+ cancer.
In 1975, Georges Köhler, César Milstein, and Niels Kaj Jerne created monoclonal antibody (mAb) technique by using a mouse x mouse hybridoma. They shared the Nobel Prize in Medicine in 1984 for the discovery. Eight years later, in 1992 US FDA approved the first therapeutic mAb muromonab-CD3 (trade name Orthoclone OKT3) to reduce acute rejection in patients with organ transplants. Since then, genetic engineering technique was developed and used into preparation of humanized mAb. as of December 22, 2022, FDA has approved 151 therapeutic mAbs (not including two diagnostic mAb).
Among them total 58 of the mAbs are approved for treatment of cancer [1]. This mini review focuses briefly on the characteristics of total 12 anti-HER2 therapeutic antibodies approved by FDA for the treatment of breast cancer (Table) [2-13].
|
Anti-HER2 Monoclonal Antibodies Approved By FDA |
||||||
|
Approval on |
MAH |
Drug Name |
Active Ingredients |
Indication |
Boxed Warning |
Adverse Events |
|
09/25/1998 |
GENEN TECH |
HERCEPTIN |
trastuzumab |
Adjuvant Breast Cancer; Metastatic Breast Cancer; Metastatic Gastric Cancer |
Cardiomyopathy; Infusion Reactions, Pulmonary Toxicity; Embryo-Fetal Toxicity |
headache, diarrhea, nausea, and chills; congestive heart failure; neutropenia |
|
06-08-2012 |
GENEN TECH |
PERJETA |
pertuzumab |
metastatic breast cancer (MBC); Early Breast Cancer (EBC) |
Left Ventricular Dysfunction; Embryo-fetal Toxicity |
diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy |
|
02/22/2013 |
GENEN TECH |
KADCYLA |
ado-trastuzumab emtansine (ADC Antibody Drug Conjugate, microtubule inhibitor) |
metastatic breast cancer (MBC); Early Breast Cancer (EBC) |
Hepatotoxicity, liver failure and death; reductions in left ventricular ejection fraction (LVEF) |
fatigue, nausea, musculoskeletal pain, hemorrhage, thrombocytopenia, headache, increased transaminases, constipation and epistaxis |
|
02/28/2019 |
GENEN TECH |
HERCEPTIN HYLECTA |
trastuzumab and hyaluronidase-oysk (Hyaluronidase increases absorption) |
Adjuvant Breast Cancer; Metastatic Breast Cancer |
Cardiomyopathy; Infusion Reactions, Pulmonary Toxicity; Embryo-Fetal Toxicity [Hypersensitivity and Administration-R elated Reactions (ARRs)] |
fatigue, arthralgia, diarrhea, injection site reaction, upper respiratory tract infection, rash, myalgia, nausea, headache, edema, flushing, pyrexia, cough, and pain in extremity. |
|
06/29/2020 |
GENEN TECH |
PHESGO |
Pertuzumab, trastuzumab, and hyaluronidase-zzxf |
Early Breast Cancer (EBC); Metastatic Breast Cancer (MBC) |
Cardiomyopathy; Embryo-fetal Toxicity; Pulmonary Toxicity: |
diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy |
|
12-01-2017 |
MYLAN GMBH |
OGIVRI Biosimilar to HERCEPTIN |
trastuzumab-dkst |
Breast Cancer; gastric or gastroesophageal junction adenocarcinoma |
Cardiomyopathy; Infusion Reactions, Pulmonary Toxicity; Embryo-Fetal Toxicity |
fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash |
|
12/14/2018 |
CELLTRION |
HERZUMA Biosimilar to HERCEPTIN |
trastuzumab-pkrb (modified Fc) |
Adjuvant Breast Cancer; Metastatic Breast Cancer; Metastatic Gastric Cancer |
Cardiomyopathy; Infusion Reactions, Pulmonary Toxicity; Embryo-Fetal Toxicity |
fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash |
|
01/18/2019 |
SAMSUNG BIOEPIS |
ONTRUZANT Biosimilar to HERCEPTIN |
trastuzumab-dttb |
Breast Cancer; gastric or gastroesophageal junction adenocarcinoma |
Cardiomyopathy; Infusion Reactions, Pulmonary Toxicity; Embryo-Fetal Toxicity |
fever, chills, headache, infection, congestive heart failure, |
|
03-11-2019 |
PFIZER |
TRAZIMERA Biosimilar to HERCEPTIN |
trastuzumab-qyyp |
Adjuvant Breast Cancer; Metastatic Breast Cancer; Metastatic Gastric Cancer |
Cardiomyopathy; Infusion Reactions, Pulmonary Toxicity; Embryo-Fetal Toxicity |
fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash. |
|
06/13/2019 |
AMGEN |
KANJINTI Biosimilar to HERCEPTIN |
trastuzumab-anns |
Adjuvant Breast Cancer; Metastatic Breast Cancer; Metastatic Gastric Cancer |
Cardiomyopathy; Infusion Reactions, Pulmonary Toxicity; Embryo-Fetal Toxicity |
fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash. |
|
12/20/2019 |
DAIICHI SANKYO |
ENHERTU |
fam-trastuzumab deruxtecan-nxki (ADC topoisomerase I inhibitor ) |
Metastatic Breast Cancer; Locally Advanced or Metastatic Gastric Cancer |
Interstitial lung disease (ILD) and pneumonitis; Embryo-Fetal Toxicity |
Neutropenia; Left Ventricular Dysfunction; fatigue, vomiting, alopecia, AST, ALT increased |
|
12/16/2020 |
MACRO GENICS |
MARGENZA |
margetuximab-cmkb (modified Fc) |
metastatic HER2+ breast cancer received >/= prior anti-HER2 regimens |
Left Ventricular Dysfunction; Embryo-Fetal Toxicity |
fatigue/asthenia, nausea, diarrhea, vomiting, constipation, headache, pyrexia, alopecia, abdominal pain, peripheral neuropath |
MAH Marketing Authorization Holder
REFERENCE
- Cai HH. (2021). Therapeutic Monoclonal Antibodies Approved by FDA in 2020. Clin Res Immunol. 4(1):1-2.
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103792s5345lbl.pdf
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125409s124lbl.pdf
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125427s108lbl.pdf
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761106Orig1s000lbl.pdf
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761074s004lbl.pdf
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761091s001s002lbl.pdf
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761100s000lbl.pdf
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761081s000lbl.pdf
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761073Orig1s000lbl.pdf
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761139s011lbl.pdf
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761150s000lbl.pdf
