FDA Orphan Drug Designation Granted to Oxaliplatin for the Treatment of Pancreatic Cancer
“Receiving a third ODD from the FDA is an important milestone as it provides additional validation of our strategy to build a multi-agent, targeted, drug-delivery oncology pipeline enabled by our patented RenovoCath device,” said Shaun Bagai, Chief Executive Officer of RenovoRx. “Our differentiated technology is designed to deliver therapeutic agents intra-arterially across the arterial wall directly near the tumor site, with potential applications across multiple therapeutic agents and multiple cancer types. The FDA’s ODD of oxaliplatin not only expands our pipeline, but also provides valuable regulatory incentives, including seven years of potential market exclusivity and a waiver of FDA application fees that can total several million dollars. While we are laser focused on finishing our current Phase III clinical trial and advancing commercialization of RenovoCath as a standalone device, we remain committed to advancing our platform and exploring the full potential of targeted oxaliplatin delivery in patients diagnosed with difficult-to-treat cancers.”
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