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Today, Daiichi Sankyo announced that the US FDA has granted patritumab deruxtecan (HER3-DXd) breakthrough therapy designation (BTD)
.
This is a potential "first-in-class" HER3 targeting antibody conjugate drug (ADC), used for the treatment of third-generation tyrosine kinase inhibitors (TKI) and platinum-containing therapy during or during treatment Later, patients with metastatic or locally advanced non-small cell lung cancer (NSCLC) who have disease progression and carry drug-resistant EGFR mutations
Lung cancer is the world's second most common cancer and the leading cause of cancer-related deaths, of which 80%-85% are NSCLC
.
Approximately 15%-50% of NSCLC patients carry EGFR mutations
Patritumab deruxtecan is designed with Daiichi Sankyo's proprietary DXd ADC technology, and is composed of a humanized anti-HER3 antibody and a topoisomerase I inhibitor (topoisomerase I inhibitor) payload connected through a tetrapeptide linker
.
▲Introduction of Patritumab deruxtecan (U3-1402) (Image source: Daiichi Sankyo official website)
This breakthrough therapy designation is based on the positive data currently obtained in a three-cohort phase 1 clinical trial of the drug
.
The results published in the American Society of Clinical Oncology (ASCO) in 2021 showed that 57 enrolled patients treated with patritumab deruxtecan (5.
Reference materials:
[1] Patritumab Deruxtecan Granted US FDA Breakthrough Therapy Designation in Patients with Metastatic EGFR-Mutated Non-Small Cell Lung Cancer.
(The original text has been deleted)
