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Thomas Flaig, MD


FDA Brief: Fast Track Designation Granted to Belzupacap Sarotalocan in Bladder Cancer

By: JNCCN 360 Staff
Posted: Monday, July 11, 2022

Aura Biosciences recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to belzupacap sarotalocan (AU-011), a novel virus-like drug conjugate that consists of a virus-like particle conjugated with an anticancer agent, in the treatment of non–muscle-invasive bladder cancer.

A planned phase I clinical trial of belzupacap sarotalocan in this bladder cancer indication will evaluate the safety and early proof of mechanism as well as assess distribution, local necrosis, and evidence of immune activation. The trial is expected to be initiated in the second half of 2022, with initial phase I data expected in 2023.

Belzupacap sarotalocan has also been previously granted Fast Track and Orphan Drug designations by the FDA for the treatment of the intraocular tumor choroidal melanoma. It is currently in phase II clinical development for this indication.

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