FDA Grants Breakthrough Therapy Designation to DS-8201 for HER2+ Breast Cancer

Share this content:
DS-8201 is an investigational HER2-targeting ADC, a targeted therapy for cancer that delivers cytotoxic chemotherapy by means of a linker on the monoclonal antibody that attaches to a specific target
DS-8201 is an investigational HER2-targeting ADC, a targeted therapy for cancer that delivers cytotoxic chemotherapy by means of a linker on the monoclonal antibody that attaches to a specific target

The US Food and Drug Administration (FDA) granted Breakthrough Therapy designation to DS-8201 for the treatment of patients with locally advanced or metastatic, HER2-positive breast cancer who have been treated with trastuzumab, pertuzumab, and have progressed after ado-trastuzumab emtansine (T-DM1).1

DS-8201 is an investigational HER2-targeting antibody drug conjugate (ADC), a targeted therapy for cancer that delivers cytotoxic chemotherapy by means of a linker on the monoclonal antibody that attaches to a specific target on cancer cells.

Breakthrough therapy designation was granted based on evidence from an ongoing 2-part stage 1 dosing trial (ClinicalTrials.gov Identifier: NCT02564900) evaluating the safety and efficacy of DS-8201. A maximum tolerated dose was not reached and no dose-limiting toxicities were reported in the phase 1 study.

Preliminary results demonstrated that patients achieved a 46.7% overall response rate (ORR) (14 of 30 patients) and a 100% disease control rate. Patients who were previously treated with T-DM1 achieved an ORR of 45.7% (16 of 35 patients) and a 100% disease control rate.2

References

  1. FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo's DS-8201 for HER2-Positive Metastatic Breast Cancer [news release]. Tokyo, Japan, Basking Ridge, NJ, and Munich, Germany: PRNewswire; August 29, 2017. https://prnmedia.prnewswire.com/news-releases/442102363.html?tc=PRNJ_email_html_headlines. Accessed August 29, 2017.
  2. New Precision Medicine Data on DS-8201 in HER2-Expressing Breast Cancer Revealed at 2017 American Society of Clinical Oncology (ASCO) Annual Meeting [news release]. Tokyo, Japan, Parsippany, NJ, and Munich, Germany: Daiichi-Sankyo. June 6, 2017. http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006641.html. Accessed August 29, 2017

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs

Sign Up for Free e-newsletters