Oncoinvent's Radspherin® IND Application Gains FDA Approval for Targeting Colorectal Cancer

Monday, October 30, 2023

Oncoinvent AS, a clinical-stage company focused on advancing alpha emitter therapy for various solid cancer types, has reached a significant milestone. The company announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application, marking a pivotal moment in the journey of its Phase 2b study for Radspherin® in patients with peritoneal carcinomatosis caused by colorectal cancer. This development represents a crucial step in Oncoinvent's expansion into the U.S. healthcare landscape.

In the ongoing Phase 1/2a clinical trials involving Radspherin®, all administered dose levels have proven to be well-tolerated. The recommended dose of 7MBq has been selected based on these findings. Notably, Oncoinvent recently presented preliminary 18-month safety and efficacy data from the ongoing RAD-18-002 study, which included patients with peritoneal carcinomatosis from colorectal cancer. Encouragingly, none of the 12 patients who received the recommended 7 MBq dose experienced peritoneal recurrences after 18 months.

The newly cleared trial, expected to commence in the second quarter of 2024, is a randomized controlled Phase 2b study. It aims to evaluate the efficacy and safety of Radspherin® in patients with peritoneal carcinomatosis stemming from colorectal carcinoma following cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The primary objective of this trial is to compare progression-free survival (PFS) between patients who undergo CRS and HIPEC followed by Radspherin® and those who receive only CRS and HIPEC.


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