Core Viewpoint - Eli Lilly (LLY.US) announced that the FDA has granted breakthrough therapy designation for sofetabart mipitecan (LY4170156) for the treatment of adult platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in patients who have previously received bevacizumab and meet the treatment criteria [1] Group 1: Drug Development - LY4170156 is an FRα ADC drug developed by Mablink Bioscience, which has been acquired by Eli Lilly, utilizing proprietary linker technology and carrying irinotecan as the active payload with a DAR value of 8 [1] - The breakthrough therapy designation was based on positive preliminary data from the Phase Ia/b study, indicating that the drug shows efficacy across various dose levels and is not limited by the patient's FRα expression levels [1] Group 2: Clinical Results - Preliminary data suggest that LY4170156 has good tolerability, with low incidence rates of adverse reactions such as interstitial lung disease, peripheral neuropathy, and alopecia, and no significant ocular toxicity observed [1]
礼来(LLY.US)FRα ADC获FDA突破性疗法认定