Eli Lilly (NYSE:LLY) shares gained after the U.S. Food and Drug Administration granted Breakthrough Therapy designation to its experimental antibody-drug conjugate, potentially accelerating the path to market for a treatment targeting hard-to-treat gynecologic cancers.
The designation for sofetabart mipitecan (LY4170156) applies to adult patients with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer.
Specifically, the status covers those who have previously received bevacizumab and mirvetuximab soravtansine—a patient population currently facing limited therapeutic options.
The FDA’s decision was supported by preliminary Phase 1a/b clinical data, which demonstrated anti-tumor activity across varying levels of folate receptor alpha (FRα) expression, as well as a manageable safety profile with low rates of typical chemotherapy side effects like hair loss and nerve damage.
Lilly has already moved to capitalize on the early success, initiating the global Phase 3 FRAmework-01 trial to evaluate the drug as a monotherapy and in combination with other treatments.
The drug utilizes a proprietary linker and an exatecan payload to deliver toxic agents directly to cancer cells.