Lilly's Ovarian Cancer Drug Candidate Receives FDA Breakthrough Therapy Designation

Eli Lilly and Company announced the FDA granted Breakthrough Therapy designation to its investigational drug, sofetabart mipitecan.

The designation targets adult patients with platinum-resistant ovarian cancer.

This status expedites development and review for drugs showing potential substantial improvement over existing therapies.

Sofetabart mipitecan is a novel folate receptor alpha (FRα) antibody-drug conjugate (ADC).

The FDA based its decision on promising preliminary clinical evidence.

Lilly initiated the Phase 3 trial, FRAmework-01, to evaluate the therapy's potential.

This milestone addresses the significant unmet need for new treatments in this patient population.