Curium Submits NDA for Lutetium Lu 177 Dotatate Injection
Wednesday, July 10, 2024
Curium, a leader in nuclear medicine, announced today the submission of a 505(b)(2) New Drug Application for Lutetium Lu 177 Dotatate Injection. This application seeks FDA approval for treating somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETS). This marks a significant step in Curium's strategy to establish itself in nuclear medicine therapeutics.
Curium has developed its formulation over several years, ensuring it complies with patent regulations to expedite market entry. The company aims to redefine cancer treatment through its extensive experience in nuclear medicine.
Curium plans to collaborate closely with the FDA throughout the review process and hopes to broaden access to radioligand therapy benefits for GEP-NETS patients.
Michael Patterson, CEO of Curium North America, stated, "Curium’s 505(b)(2) new drug application for Lutetium Lu 177 Dotatate Injection is a pivotal milestone as we continue to innovate for patients and healthcare providers. Expanding access to nuclear medicine-based cancer therapies is crucial."
Curium will provide updates as it progresses through the FDA's review process.
Source: globenewswire.com
