Express AstraZeneca/Daiichi Sankyo's blockbuster ADC won the 5th breakthrough therapy designation for the treatment of HER2 low-expressing breast cancer

▎WuXi AppTec Content Team Editor A few days ago, AstraZeneca and Daiichi Sankyo jointly announced that the U.
S.
FDA granted breakthrough therapy designation to Enhertu, the blockbuster antibody-drug conjugate (ADC) jointly developed by the two parties.
for the treatment of patients with unresectable or metastatic breast cancer with low HER2 expression
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They had received one prior therapy in the setting of metastatic cancer, or had disease recurrence within 6 months of receiving adjuvant chemotherapy or completing adjuvant chemotherapy
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According to the press release, this is the fifth breakthrough therapy designation for Enhertu
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Enhertu is an ADC drug designed using Daiichi Sankyo's proprietary DXd ADC technology platform, consisting of a humanized monoclonal antibody targeting HER2 linked to a topoisomerase 1 inhibitor payload through a tetrapeptide cleavable linker
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Enhertu has previously been FDA-approved as a third-line treatment for patients with previously treated HER2-positive unresectable or metastatic HER2-positive breast cancer, as well as HER2-positive locally advanced or metastatic gastric cancer and gastroesophageal junction (GEJ) glands treated with trastuzumab-based therapy cancer patients
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The Breakthrough Therapy designation was granted based on positive data from the pivotal Phase 3 clinical trial DESTINY-Breast04
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Enhertu provided clinically meaningful and statistically significant improvements in patients' progression-free survival and overall survival compared to physician's choice of chemotherapy, the current standard of care
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Specific results of the trial will be presented at an upcoming medical meeting
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"Historically, only patients with HER2-positive metastatic breast cancer have been shown to benefit from HER2-targeted therapy
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In DESTINY-Breast04, Enhertu provided a clinically meaningful survival benefit in patients with metastatic breast cancer with low HER2 expression
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Screening patients based on low HER2 expression has the potential to change the diagnostic and treatment paradigm for these patients
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"This breakthrough therapy designation is a recognition of Enhertu's potential to meet this unmet medical need, and we look forward to working closely with the FDA to bring the first HER2-targeted therapy to the market," said Dr.
Ken Takeshita, Global Head of R&D at Daiichi Sankyo.
this patient group
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” Reference: [1] ENHERTU® Granted Breakthrough Therapy Designation in US for Patients with HER2 Low Metastatic Breast Cancer.
Retrieved April 27, 2022, from https:// %C2%AE-Granted-Breakthrough-Therapy-Designation-in-US-for-Patients-with-HER2-Low-Metastatic-Breast
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