Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for its drug candidate, sofetabart mipitecan.
The designation covers adult patients with a specific form of platinum-resistant ovarian cancer who have received prior treatments.
The FDA based its decision on encouraging initial results from a Phase 1 study.
Sofetabart mipitecan is a novel antibody-drug conjugate.
The designation accelerates development and review for drugs where preliminary clinical evidence indicates substantial improvement over available therapies.
Lilly has already initiated a Phase 3 trial to evaluate the potential therapy.