FDA Grants Breakthrough Therapy Status to Sofetabart Mipitecan for Ovarian Cancer Treatment.

Eli Lilly's sofetabart mipitecan has been granted Breakthrough Therapy designation by the FDA for treating platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who have received prior bevacizumab and mirvetuximab soravtansine. Sofetabart mipitecan is a novel folate receptor alpha antibody-drug conjugate that uses proprietary linker technology and an exatecan payload. The designation aims to expedite the development and review of the drug, which has shown substantial improvement over available therapy.