ITM Isotope Technologies Munich (ITM) has introduced Lumara Bio as a dedicated oncology therapeutics division combining the company's existing radiopharmaceutical pipeline and the internal teams supporting its development and commercialization.
Lumara Bio will focus resources toward commercial readiness for ITM's lead drug candidate, lutetium-177 (Lu-177) edotreotide (ITM-11), which is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2026, according to the company.
Beyond ITM-11, Lumara Bio will advance ITM's early- and late-stage pipeline of targeted radiopharmaceutical candidates spanning multiple cancer types, treatment approaches, and isotope platforms, the company said. The division will draw on ITM's isotope manufacturing and supply operations to support its pipeline and potential U.S. commercial launch activities.
