China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that its trastuzumab rezetecan (SHR-A1811), an HER2-targeted antibody-drug conjugate (ADC), is on course to receive its 8th Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The targeted indication is recurrent or metastatic cervical cancer with HER2 expression (IHC≥1+) in patients who have failed previous treatment with platinum-containing chemotherapy and immune checkpoint inhibitors.
Drug Profile and Previous Designations
Trastuzumab rezetecan is an anti-HER2 ADC designed to target cancer cells expressing HER2. The drug has already received BTDs for seven indications, including breast cancer, non-small cell lung cancer (NSCLC), colorectal cancer, gastric or gastroesophageal junction (G/GEJ) cancer, biliary tract cancer, and primary peritoneal cancer. In September 2024, the marketing authorization application for trastuzumab rezetecan was accepted by the NMPA and set for priority review for the treatment of locally advanced or metastatic HER2-mutated adult NSCLC patients who have previously received at least one systemic therapy.-Fineline Info & Tech
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