Home / Health / FDA Approves Novel Bile Duct Cancer Treatment
FDA Approves Novel Bile Duct Cancer Treatment
17 Aug
Summary
- FDA grants humanitarian device exemption for OncoSil to treat rare bile duct cancer.
- OncoSil delivers targeted beta radiation directly into tumors, sparing healthy organs.
- Rollout limited to five US centers for post-approval safety and benefit study.
The US Food and Drug Administration (FDA) has issued a humanitarian device exemption (HDE) for OncoSil Medical's OncoSil platform, marking a significant milestone for the Australian company. This approval authorizes the device for treating distal cholangiocarcinoma (dCCA), a rare and aggressive form of bile duct cancer. The OncoSil technology works by precisely delivering targeted beta radiation therapy directly into tumors, aiming to destroy cancer cells while minimizing damage to adjacent healthy tissues. This advancement offers a new therapeutic avenue for patients in the US, where dCCA is diagnosed in approximately 10,000 individuals annually, often with poor survival outcomes.
The HDE mandates that OncoSil's US launch will commence at a maximum of five carefully selected treatment centers. These initial sites will participate in a post-approval study (PAS) designed to further evaluate the safety and potential benefits of the device in adults aged 21 and above with unresectable and non-metastatic dCCA. This prospective study is expected to enroll 30 patients and monitor them for up to 24 months. OncoSil anticipates making its device available in the US by the second quarter of fiscal year 2027.
