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FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo’s DS-8201 for HER2-Positive Metastatic Breast Cancer.
From: PR Newswire — Breakthrough Therapy designation received for the treatment of patients with HER2-positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after ado-trastuzumab emtansine (T-DM1) — HER2-positive metastatic breast cancer often advances to the point where no currently approved HER2-targeted treatments continue to control the disease — Designation based on preliminary clinical evidence highlights that DS-8201 has the potential to offer substantial clinical benefit to patients with a high unmet medical need Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to DS-8201, an investigational HER2-targeting antibody drug conjugate (ADC), for the treatment of patients with HER2-positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after ado-trastuzumab emtansine (T-DM1).
Currently, there is no FDA-approved therapy for patients with HER2-positive metastatic breast cancer with disease progression following treatment with other HER2-targeting agents trastuzumab, pertuzumab and T-DM1.
“The Breakthrough Therapy designation for DS-8201 in HER2-positive metastatic breast cancer acknowledges the unmet medical need these patients face when currently approved treatments no longer control their disease,” said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo.
“We remain committed to rapidly progressing the development of DS-8201 and look forward to working closely with the FDA to potentially bring this new treatment option to patients with metastatic breast cancer as quickly as possible.” The Breakthrough Therapy designation was granted based on the results of the ongoing phase 1 study assessing the safety, tolerability and preliminary efficacy of DS-8201.
ADCs are a type of targeted cancer medicine that deliver cytotoxic chemotherapy (“payload”) to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells.
In addition to Breakthrough Therapy designation, the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DS-8201 for the treatment of HER2-positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including T-DM1.
DS-8201 is currently in phase 1 clinical development for HER2-positive advanced or metastatic breast cancer and gastric cancer, HER2 low-expressing breast cancer and other HER2-expressing solid tumors.
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For more information on Daiichi Sankyo, Inc., please visit: www.dsi.com.