stay tuned:
elixi news from the
world

Enhertu (fam-trastuzumab deruxtecan-nxki), new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies

Enhertu (fam-trastuzumab deruxtecan-nxki), new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies

The U.S. Food and Drug Administration granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. Enhertu is a human epidermal growth factor receptor 2 (HER2)-directed antibody and topoisomerase inhibitor conjugate, meaning that the drug targets the changes in HER2 that help the cancer grow, divide and spread, and is linked to a topoisomerise inhibitor, which is a chemical compound that is toxic to cancer cells.

“There have been many advances in the development of drugs for HER2-positive breast cancer since the introduction of Herceptin (trastuzumab) in 1998. The approval of Enhertu represents the newest treatment option for patients who have progressed on available HER2-directed therapies,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “Drug development in the area of targeted therapies builds on our scientific understanding of malignant diseases not only in breast cancer, but in multiple other diseases.”

HER2-positive breast cancer is a type of breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. Approximately one of every five breast cancers have a gene mutation in the cancer cells that makes an excess of the HER2 protein. HER2-positive breast cancers are an aggressive type of breast cancer.

Enhertu’s approval was based on the results of a clinical trial enrolling 184 female patients with HER2-positive, unresectable and/or metastatic breast cancer who had received two or more prior anti-HER2 therapies in the metastatic setting. These patients were heavily pretreated in the metastatic setting, receiving between two and 17 therapies prior to receiving Enhertu. Patients in the clinical trial received Enhertu every three weeks and tumor imagining was obtained every six weeks. The overall response rate was 60.3%, which reflects the percentage of patients that had a certain amount of tumor shrinkage with a median duration of response of 14.8 months.

For more information and fast delivery of the life-saving, latest FDA approved oncology drugs, please contact us at info@elixi-int.com

We are a Swiss pharmaceutical wholesaler, specialised in sourcing and delivering pharma products, medical devices and drugs from and to all over the world

Share this article

Share on twitter
Tweet
Share on facebook
Share
Share on pinterest
Pin it
Share on linkedin
Share

SEE Also

we are specialized in the procurement and distribution of pharmaceutical products, medical devices all over the world

Stay Tuned

Subscribe to our newsletter

Contact us

ELIXI International SA

Vicolo Oldelli 1
6830 Chiasso / Switzerland
Email info@elixi-int.com
Phone/Fax +41 91 6822040

ELIXI International SA

Copyright 2019 ELIXI International SA.   |   All Rights Reserved   |   Privacy Policy   |   Cookie Policy   |   Credits ATG Suisse