Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to sofetabart mipitecan (LY4170156) for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received prior bevacizumab and mirvetuximab soravtansine, if eligible. The designation was based on encouraging preliminary results from a Phase 1a/b study. Sofetabart mipitecan, a novel folate receptor alpha antibody-drug conjugate, has advanced into the Phase 3 FRAmework-01 study, which is being conducted globally in partnership with the European Network for Gynaecological Oncological Trial groups, the GOG Foundation, and the Asia-Pacific Gynecologic Oncology Trials Group.

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