Oncoinvent has received fast-track designation from the US Food and Drug Administration (FDA) for its therapy, Radspherin, to treat peritoneal metastases from ovarian cancer. The process expedites the development and review of products targeting serious conditions with unmet medical needs, potentially enabling earlier patient access to new medicines. The gold standard of business intelligence.
Fast-track status will offer Oncoinvent the advantage of more frequent interactions with the FDA throughout the clinical development of Radspherin. The designation makes it a candidate for accelerated approval and priority review. A lead candidate of the company, Radspherin is currently being evaluated in two active clinical studies for the treatment of peritoneal carcinomatosis resulting from both ovarian and colorectal cancer.
An ongoing controlled, randomised Phase IIb clinical trial is assessing the safety and efficacy of Radspherin in patients with ovarian cancer-derived peritoneal metastases. Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research.
Gain competitive edge. Your download email will arrive shortly We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form The trial’s primary goal is to compare progression-free survival rates between patients receiving Rads.