The US Food and Drug Administration (FDA) has granted OncoSil Medical a humanitarian device exemption (HDE) approval for its namesake platform in the treatment of a rare type of bile duct cancer.

As per the HDE, the OncoSildevice is authorised to treat distal cholangiocarcinoma (dCCA). The technology works by delivering targeted beta radiation therapy directly into tumours via injection, which destroys cancer cells while protecting nearby healthy organs. The HDE for dCCA follows the platform’s EU clearance for locally advanced pancreatic cancer in 2020.

Around 10,000 patients in the US are diagnosed with dCCA each year, according to the Cholangiocarcinoma Foundation. The cancer is associated with poor survival outcomes, with median overall survival (OS) as low as 6.7 months, given the cancer often grows silently and is diagnosed late, with palliative stenting, standard chemotherapy, and general radiation providing limited effectiveness.