On October 20, 2025 Tallac Therapeutics reported that the U.S. Food and Drug Administration has granted Fast Track designation to TAC-001 for the treatment of previously treated, locally advanced unresectable or metastatic cholangiocarcinoma.

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Cholangiocarcinoma (CCA) is an aggressive malignancy of the biliary tract with a poor overall prognosis and limited treatment options. The majority (~70%) of patients are diagnosed late at advanced stages and have a 5-year survival rate of less than 10%. Current treatment options, particularly for patients who relapsed after prior systemic treatment, are limited. The designation highlights TAC-001’s potential to address this urgent medical need.

Building on encouraging safety and efficacy Ph1 data in solid tumors, the Fast Track designations will greatly support the clinical development strategy to advance TAC-001, a next-generation antibody-drug conjugate (ADC) designed to safely and efficiently engage both the innate and adaptive anti-tumor immune response.

(Press release, Tallac Therapeutics, OCT 20, 2025, View Source [SID1234656825])