New HER2 Positive Breast Cancer Treatments 2022

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What is HER2 positive breast cancer?¹

Human epidermal growth factor receptor 2 (HER2) is a growth-promoting protein on the outside of all breast cells. Breast cancer cells with higher than normal levels of HER2 are called HER2-positive. Such cancers tend to grow and spread faster than other breast cancers, but are much more likely to respond to treatment with drugs that target the HER2 protein. There are several her2 targeted therapies.

What are the newest HER2 positive breast cancer medicines available?

Several medicines have been approved or are under clinical trial as HER2 positive breast cancer targeted therapies.

Here are some of them:

Enhertu (fam-trastuzumab-deruxtecan-nxki) ^2,3,4

Enhertu (fam-trastuzumab-deruxtecan-nxki) is used for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have been treated previously for their metastatic cancer.

It is a combination of an anti-HER2 medicine that has the same basic structure as Herceptin, the chemotherapy medicine topoisomerase I inhibitor, and deruxtecan, a compound that links the other two together. Enhertu was designed to deliver topoisomerase I inhibitor to cancer cells in a targeted way by attaching the topoisomerase I inhibitor to the anti-HER2 medicine, which then carries the chemotherapy to the HER2-positive cancer cells.

On 20 December 2019, the Food and Drug Administration (FDA), USA granted Enhertu (fam-trastuzumab deruxtecan-nxki) with an accelerated approval for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. On 25 March 2020, the Pharmaceuticals and Medical Devices Agency (PMDA), Japan approved Ehertu (fam-trastuzumab deruxtecan-nxki) for the treatment of patients with HER2 positive unresectable or recurrent breast cancer after prior chemotherapy (limit the use to patients who are refractory or intolerant to standard treatments).

Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) ⁵

Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) is combined with intravenous chemotherapy for the treatment of adults with HER2-positive breast cancer that has metastasized, and of adult patients with early HER2-positive breast cancer.

Phesgo is an anti-HER2 medicine (immunotherapy). It is a fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf. The pertuzumab and trastuzumab are there to attack the cancer cells, and the hyaluronidase is there to help your body absorb these 2 medicines.

On June 29 2020, The Food and Drug Administration (FDA), USA approved Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) for the treatment of adult patients with metastasized HER2-positive breast cancer, and for treatment of adult patients with early HER2-positive breast cancer.

Piqray (alpelisib) ^{6, 7}

Piqray (alpelisib) is used in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

Piqray (alpelisib) is a kinase inhibitor indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CAmutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

Piqray (alpelisib) was approved for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CAmutated, advanced or metastatic breast cancer by the Food and Drug Administration (FDA), USA, on May 24, 2019 and the European Medicines Agency (EMA), Europe, on July 29, 2020.

Tukysa (tucatinib)

Tukysa (tucatinib) is used in combination with trastuzumab and capecitabine for the treatment of adult patients with advanced, unresectable or metastatic HER2-positive breast cancer.

Tukysa (tucatinib) is a tyrosine kinase inhibitor that is indicated for use in combination with trastuzumab and capecitabine for the treatment of adult patients with advanced, inoperable or metastatic HER2-positive breast cancer. This includes patients with cancer that has spread to the brain, and who have received prior treatment with trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1).

Tukysa (tucatinib) in combination with trastuzumab and capecitabine for the treatment of adult patients with previously treated inoperable or metastatic HER2-positive breast cancer was approved by:

• The Food and Drug Administration (FDA), USA, on April 17, 2020. ⁸
• Swissmedic, Switzerland, on May 12, 2020.⁹
• Health Science Authority, Singapore on May 19, 2020.¹⁰
• Health Canada, Canada, on June 3, 2020.¹¹
• Therapeutic Goods Administration (TGA), Australia, on August 12, 2020.¹²

Margenza (margetuximab-cmkb)¹³

Margenza (margetuximab-cmkb) is the first HER2-targeted therapy to have improved progression-free survival (PFS) versus Herceptin® (trastuzumab), both combined with chemotherapy, in a head-to-head Phase 3 clinical trial (SOPHIA).

On December 16 2020, The Food and Drug Administration (FDA), USA has approved Margenza (margetuximab-cmkb), in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.

Margenza (margetuximab-cmkb) is expected to be available in March of 2021.

How can I access a new HER2 positive breast cancer medicine?

If you are trying to access a HER2 positive breast cancer medicine that is approved outside of your country of residence, we might be able to help you access it with the help of your treating doctor. You can read more about the medicines we can help you access and their prices below:

Enhertu (fam-trastuzumab deruxtecan-nxki)

Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf)

Piqray (alpelisib)

Tukysa (tucatinib)

View all

Why access a HER2-positive breast cancer medicine with everyone.org?

everyone.org is registered in The Hague with the Dutch Ministry of Health (registration number 16258 G) as a pharmaceutical wholesale distributor. We have helped patients from over 85 countries to access thousands of medicines including. With a prescription from your treating doctor, you can count on our expert team to safely and legally guide you to access breast cancer drugs. If you or someone you know are looking to access a medicine that is not yet approved where they live, we can support you. Contact us for more information.

References:

1. Cancer.org
2. Breastcancer.org
3. Fda.gov
4. Daiichisankyo.com
5. Accessdata.org
6. Accessdata.org
7. Ema.europa.eu
8. Fda.gov
9. Investor.seagen.com
10. Hsa.org
11. Health Canada
12. Tga.gov

Disclaimer: This article is not meant to influence or impact the care provided by your treating physician. Please do not make changes to your treatment without first consulting your healthcare provider. This article is not intended to diagnose or treat illness or to influence treatment options. everyone.org is as diligent as possible in compiling and updating the information on this page. However, everyone.org does not guarantee the correctness and completeness of the information provided on this page.