On August 27, 2026 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Varseta-M for the treatment of patients with relapsed/refractory metastatic colorectal cancer. Varseta-M is a potential first-in-class antibody drug conjugate directed toward epithelial cell adhesion molecule (EpCAM) with a topoisomerase-1 inhibitor payload.
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"Varseta-M was intentionally designed for patients with colorectal cancer based on the high expression of EpCAM in this cancer type. Receiving Fast Track Designation is an important milestone for the program and reflects its potential to address a highly unmet medical need in patients with relapsed/refractory metastatic colorectal cancer where we continue to work towards a planned first registrational trial in the first half of 2027," said Dr. Sean McCarthy, chairman and CEO of CytomX Therapeutics.
Fast Track Designation is intended to facilitate development and expedite the review of therapies for serious conditions with unmet medical needs.
(Press release, CytomX Therapeutics, AUG 27, 2026, View Source [SID1234670401])