FDA Approves MARGENZA

On December 16, 2020, the FDA approved margetuximab-cmkb (MARGENZA®) in combination with chemotherapy, for treating metastatic HER2-positive breast cancer.

What is Next-Generation Sequencing?

Next-generation sequencing (NGS) is when all of the genes in a tumor are tested for genomic mutations. Read the discussions about whether NGS improves survival and quality of life, and the ESMO recommendations regarding NSG for patients with metastatic cancers (including breast).

FDA Approves PHESGO

In late June, the FDA approved PHESGO (pertuzumab/ trastuzumab/ hyaluronidase-zzxf), a treatment that can be injected under the skin, to treat metastatic and early-stage HER2 positive breast cancer. Because it is given as an injection, PHESGO can be given by a healthcare professional in your home, and takes less time than an infusion.

FDA Approves PHESGO for Treatment of Patients With HER2-Positive Breast Cancer Approximately Four Months Ahead of Schedule

 

HER2 Positive Metastatic Breast Cancer Research Update

The treatment landscape for HER2 positive metastatic breast cancer has been rapidly evolving. Since February, the FDA has approved three new drugs to treat it: neratinib, tucatinib, and trastuzumab deruxtecan. More continue to look promising in clinical trials. Targeted therapies’ drugs that can attach to certain features of cancer cells have created more research avenues and may potentially lead to more treatment options.

To learn more about what it means to be HER2 positive, how the subtype is typically treated, the latest news in research, and what might be coming down the line, check out the information below.

What Does HER2 Positive Mean?
  • Breast Cancer HER2 Status  The American Cancer Society describes, in simple terms, what HER2 positive means and what test doctors use to determine whether a tumor is HER2 positive or HER2 negative.
How HER2 Positive is Typically Treated 
What’s New in HER2 Positive MBC
What’s in the Pipeline?
  • Emerging Areas in Metastatic Breast Cancer Treatment  Susan G. Komen breaks down treatments on the rise and under study for metastatic breast cancer. For HER2 positive disease, the most helpful sections are HER2 Targeted Therapies, HER2 antibody drug conjugates, and Tyrosine kinase inhibitors.
  • Clinical Trials for HER2 Positive MBC Metastatic Trial Search provides a list of over 100 clinical trials for people with HER2 positive metastatic breast cancer.

See all articles on this site tagged with HER2 Positive breast cancer

Recent FDA Approvals for Metastatic Breast Cancer

June 2020

Recent FDA Approvals for Metastatic Breast Cancer

For the past two months, Metastatic Trial Talk brought you the latest about cancer and COVID-19. But while the world focused on coping with the pandemic, the Food and Drug Administration kept drug approvals moving. It approved in April two new medicines for metastatic breast cancer: tucatinib (Tukysa®), for HER2-positive disease, and sacituzumab govetican (Trodelvy®), for triple-negative disease.

Below, read about the FDA approval of each new medicine, who might benefit the most, how the treatments are given and what side effects each may cause. In addition, you’ll find information on the approval of a third drug, trastuzumab deruxtican (Enhertu®), announced in late December.

Tucatinib (Tukysa®)
Sacituzumab govetican (Trodelvy®)
Trastuzumab deruxtican (Enhertu®)
Relevant Topics on Metastatic Trial Talk (MTT)

Treating Brain Metastases

Studies suggest that between 15 and 30 percent of women and men with metastatic breast cancer will develop brain metastases. This number has been increasing as MBC patients live longer on treatments that control cancer growth in other areas of the body.

Clinical trials are currently looking at the best way to treat brain metastases. In September, the FDA approved neratinib (Nerlynx®) as a treatment for HER2-positive metastatic breast cancer. Its previous approval was for extended adjuvant treatment for patients with early-stage HER2+ breast cancer who have already received trastuzumab (Herceptin®).

With the links below, you can learn more about developments in treating breast cancer brain metastases and the new FDA approval. You can also find links to all the clinical trials listed on BCT for breast cancer brain metastases, including the first trial to use CAR T cell therapy to treat HER2+ brain metastases.

Insights into Treatment Resistance

Over time, cancer cells often stop responding to the treatment that is keeping the tumor in check. This is called treatment resistance.

Below you will find three articles that address different aspects of treatment resistance. The first article describes research looking into the genetics of cells that become resistant. The goal is to use this information to identify new treatments. Following that are articles about treatment resistance in ER+ breast tumors and the relationship between HER2 mutations and resistance to hormone therapies.

Looking for more information? There’s an entire journal devoted to the topic: Cancer Drug Resistance. You can find it here: CDR Journal.