Daiichi Sankyo, AstraZeneca Enhertu gets USFDA breakthrough therapy designation for certain patients with HER2 low or HER2 ultralow metastatic breast cancer
Tokyo: ENHERTU (fam-trastuzumab deruxtecan-nxki) has been granted Breakthrough Therapy Designation (BTD) in the U.S. for the treatment of unresectable or metastatic hormone receptor positive HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC >0 <1+) breast cancer patients who have received either two lines of endocrine therapy in the metastatic setting, or one line of endocrine therapy if they had demonstrated disease progression within six months of starting first-line treatment with endocrine therapy in combination with a CDK4/6 inhibitor or within 24 months of the start of adjuvant endocrine therapy.
ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).
The U.S. Food and Drug Administration (FDA) BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The medicine needs to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines.
The FDA granted this BTD based on data from the DESTINY-Breast06 phase 3 trial presented as a late-breaking oral session at the 2024 American Society of Clinical Oncology (#ASCO24) Annual Meeting.
“If approved, ENHERTU could once again change the treatment paradigm for certain patients with breast cancer, pushing past old boundaries and broadening the number of people who may be eligible for a HER2 directed therapy,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “The designation also showcases Daiichi Sankyo’s commitment to pioneering cutting-edge science to deliver medicines like ENHERTU that create new standards of care for patients with cancer.”
ENHERTU has received eight BTDs, including four in metastatic breast cancer. In addition to the new BTD, the three previous BTDs for breast cancer were for later-line HER2 low metastatic breast cancer, second-line HER2 positive metastatic breast cancer and later-line HER2 positive metastatic breast cancer. ENHERTU also received four additional BTDs, including for HER2 positive (IHC 3+) metastatic solid tumors, HER2 positive metastatic colorectal cancer, HER2 (ERBB2) mutant metastatic non-small cell lung cancer (NSCLC) and HER2 positive metastatic gastric cancer. The new BTD for ENHERTU also represents the eleventh BTD across Daiichi Sankyo’s oncology pipeline.
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