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默沙东/科伦博泰ADC疗法首获FDA突破性疗法认定 治疗非小细胞肺癌

Merck/Coronavirus ADC therapy was granted breakthrough therapy designation by the FDA for the treatment of non-small cell lung cancer.

Breakings ·  Dec 4 15:39

Merck & Co., Inc. (MRK.US) announced today that the U.S. FDA has granted breakthrough therapy designation to the investigational antibody-drug conjugate (ADC) sacituzumab tirutecan (Sac-TMT) for the treatment of advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations whose disease has progressed after receiving tyrosine kinase inhibitors (TKIs) and platinum-containing chemotherapy. Sac-TMT is an investigational ADC targeting TROP2 developed in collaboration with Merck and Coronovex (06990). The press release noted that this is the first time this therapy has received FDA breakthrough therapy designation.

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