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.
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.
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The trial’s primary goal is to compare progression-free survival rates between patients receiving Radspherin post-surgical resection after pre-operative chemotherapy and those who receive the chemotherapy and surgery alone.
Interim analysis from the Phase I/IIa safety study demonstrated promising results, with Radspherin offering a good tolerability profile.
No dose-limiting toxicity was seen at the recommended 7MBq dose.
Oncoinvent CEO Anders Månsson stated: “Fast track designation for Radspherin is a key milestone for Oncoinvent, particularly as we are on the verge of initiating a Phase IIb trial to evaluate Radspherin in peritoneal metastases from ovarian cancer, and later also in peritoneal metastases stemming from colorectal cancer patients.
“We believe we are well positioned to execute the clinical development of Radspherin in our upcoming trial and look forward to advancing this innovative product candidate to benefit patients battling this type of cancer, for whom there are limited treatment options.”
