FDA Grants Fast Track Designation to Novel Therapy for Platinum-Resistant Ovarian Cancer

By: JNCCN 360 Staff
Posted: Monday, April 14, 2025

The biopharmaceutical company OnCusp Therapeutics recently announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to CUSP06—a cadherin-6–targeting antibody-drug conjugate (CDH6 ADC) with high CDH6 binding affinity, a protease-cleavable linker, and an exatecan payload (a topoisomerase-1 inhibitor)—for the treatment of patients with platinum-resistant ovarian cancer. 

An ongoing phase I multicenter study (CUSP06-1001) is evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of CUSP06 in adults with platinum-refractory or platinum-resistant ovarian cancer and other advanced solid tumors. Early data from the trial have shown antitumor activity and a manageable safety profile, according to the manufacturer. For more information on this trial, visit ClnicalTrials.gov (NCT06234423). 

PR Newswire

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