OncoSil secures TGA approval for pancreatic cancer device

OncoSil secures TGA approval for pancreatic cancer device

By: IPP Bureau

Last updated : May 22, 2026 6:05 am



Approval of device in Australia for treating locally advanced pancreatic cancer alongside gemcitabine-based chemotherapy


OncoSil Medical has received approval from the Australian Therapeutic Goods Administration (TGA) for its OncoSil device for the treatment of locally advanced pancreatic cancer (LAPC) in combination with gemcitabine-based chemotherapy.

The approval paves the way for the device to be listed on the Australian Register of Therapeutic Goods (ARTG), enabling clinicians and patients in Australia to access the treatment for pancreatic cancer.

OncoSil is a single-use brachytherapy (internal radiation) device designed to deliver a targeted dose of beta radiation directly into cancerous tissue.

According to the company, approximately 4,353 Australians are diagnosed with pancreatic cancer each year, and the TGA approval will provide an additional therapeutic option for eligible patients.

OncoSil Medical CEO and Managing Director Nigel Lange said: “Receiving TGA approval is a proud achievement as an Australian medical technology company. Having developed this innovative treatment platform in Australia, it is incredibly significant to now secure approval in our home market.”

“This milestone not only validates the strength of our clinical and regulatory work but also enables Australian patients suffering from one of the most difficult-to-treat cancers to gain access to a new therapeutic option,” added Lange.

 

 

OncoSil pancreatic cancer TGA medical device brachytherapy gemcitabine chemotherapy Australia

First Published : May 22, 2026 12:00 am