The TGA’s decision enables the device’s entry onto the Australian Register of Therapeutic Goods (ARTG), allowing access to clinicians and patients dealing with pancreatic cancer.
OncoSil is a single-use brachytherapy (internal radiation) device and is utilised for delivering a pre-determined beta radiation dose into cancerous tissue directly.
The company states that around 4,353 Australians are diagnosed with pancreatic cancer annually, and the approval allows the device to be offered as an additional treatment option within the country.
OncoSil Medical expects this authorisation to drive increased clinical adoption and support applications for regulatory approval in other markets.