OncoSil Medical (ASX:OSL) has secured approval from the Australian Therapeutic Goods Administration for its OncoSil device to be used alongside gemcitabine-based chemotherapy for patients with unresectable locally advanced pancreatic cancer.
Nigel Lange, CEO and Managing Director, described the approval as a landmark for the company and for Australian medical technology.
He said "Receiving TGA approval is a defining moment for OncoSil Medical and an especially 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. We believe this approval will further accelerate clinical adoption and strengthen our global commercialisation strategy."
Clinical leaders welcomed the approval. Professor Nam Nguyen of the Royal Adelaide Hospital and Adelaide University said, "Pancreatic cancer remains one of the greatest unmet needs in oncology, and the availability of the OncoSil device in Australia is an important advancement for clinicians and patients. For Australian patients suffering from locally advanced pancreatic cancer (LAPC), where treatment options are often limited, access to new technologies such as OncoSil is particularly important."
He added, "Based on our extensive experience with the OncoSil device, it has demonstrated significant potential value in helping drive patients towards surgical eligibility, which remains one of the most important determinants of long-term outcomes in pancreatic cancer. In addition, the targeted nature of the treatment may provide an important additional survival benefit when integrated into multidisciplinary treatment pathways. TGA approval is a significant milestone that recognises both the innovation and potential clinical value of this therapy."
OncoSil notes that pancreatic cancer has poor survival outcomes and that about 4,353 new cases are diagnosed in Australia each year, making the new option timely for a disease with limited therapies.