Eli Lilly’s sofetabart mipitecan receives FDA’s Breakthrough Therapy designation

Eli Lilly (LLY) announced that the FDA has granted Breakthrough Therapy designation to sofetabart mipitecan 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 FDA Breakthrough Therapy designation is based on encouraging preliminary results from the Phase 1a/b study, showing responses at all dose levels and across all FRalpha expression levels, including in patients who progressed on prior mirvetuximab soravtansine. These initial data also indicate a promising tolerability profile with low rates of interstitial lung disease, peripheral neuropathy, and alopecia, and no significant ocular toxicity.