OncoSil™ (originally called BrachySil™) is a 32P-loaded microparticle developed for the treatment of pancreatic cancer. In April 2020, OncoSil obtained European CE marking approval as a brachytherapy device to treat locally advanced pancreatic cancer in combination with chemotherapy, clearing the way for marketing in both the EU and the U.K. Launch in EU was delayed to the fall, due to COVID-19.
In the US, the U.S. FDA granted breakthrough device designation was also obtained for the use of the device for treating unresectable pancreatic cancer, but marketing authorization for this product will clearly be obtained only on the basis of a pivotal Phase III trial that the company needs to run in the next years.
Leading Emitter: beta electrons (β–)