FDA Grants Breakthrough Therapy Designation to DS-8201 for HER-2-Positive Breast Cancer

Excerpt:

“The FDA granted breakthrough therapy designation to DS-8201 for the treatment of HER-2-positive locally advanced or metastatic breast cancer that progressed after treatment with other HER-2-targeting agents.

“The agency based the designation on preliminary evidence from a phase 1 study designed to evaluate the safety, tolerability and efficacy of DS-8201 (Daiichi Sankyo), an investigational HER-2-targeting antibody-drug conjugate.”

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Novel HER2-Targeting Antibody-Drug Conjugate Shows Broad Antitumor Activity

Excerpt:

“A novel HER2-targeting antibody-drug conjugate showed promising antitumor activity across multiple tumor types, including HER2-postive breast cancer, according to phase I data presented at the 2016 ESMO Congress.

” ‘Antibody-drug conjugates represent promising drugs with a wider therapeutic window by effecting efficient and specific drug delivery to oncogene expressing tumor cells,’ explained lead author Kenji Tamura, MD, PhD, chairman, Department of Breast and Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.”

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