Mathews Journal of Immunology & Allergy

2575-9523

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

  1. Cai HH. (2021). Therapeutic Monoclonal Antibodies Approved by FDA in 2020. Clin Res Immunol. 4(1):1-2.
  2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103792s5345lbl.pdf
  3. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125409s124lbl.pdf
  4. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125427s108lbl.pdf
  5. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761106Orig1s000lbl.pdf
  6. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf
  7. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761074s004lbl.pdf
  8. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761091s001s002lbl.pdf
  9. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761100s000lbl.pdf
  10. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761081s000lbl.pdf
  11. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761073Orig1s000lbl.pdf
  12. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761139s011lbl.pdf
  13. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761150s000lbl.pdf

 


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