The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Oncoinvent’s Radspherin for the treatment of patients with peritoneal metastases from ovarian cancer.
Oncoinvent is a clinical stage radiopharmaceutical company advancing alpha emitter therapy across a variety of peritoneal metastases.
“Fast Track designation for Radspherin® is a key milestone for Oncoinvent, particularly as we are on the verge of initiating a Phase 2b trial to evaluate Radspherin® in peritoneal metastases from ovarian cancer, and later also in peritoneal metastases stemming from colorectal cancer patients,” said Anders Månsson, Chief Executive Officer of Oncoinvent.
“Importantly, this designation reinforces the urgent need for safe and effective therapies for patients suffering from peritoneal metastases. These metastases have a particularly negative impact on life expectancy and effective treatment therefore has a significant chance of affecting overall survival in these 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.”
The randomized, controlled Phase 2b trial will assess the efficacy and safety of Radspherin® in patients with peritoneal metastases from ovarian cancer. The primary objective is to compare progression free survival (PFS) between patients who receive Radspherin® after complete surgical resection following pre-operative chemotherapy and patients who only undergo pre-operative chemotherapy and surgery. Positive data from the Phase 1/2a safety interim analysis demonstrated that Radspherin® was well tolerated with no dose-limiting toxicity observed with the administration of the recommended dose of 7MBq.
Fast Track designation is a process that is designed to facilitate the development and expedite the review of therapies intended to treat serious conditions and address unmet medical needs to potentially bring important new medicines to patients earlier. Companies whose programs are granted Fast Track designation are eligible for more frequent interactions with the FDA during clinical development. Provided relevant criteria are met, programs with Fast Track designation are eligible for accelerated approval and priority review as well.
