Onco-Summaries: Daily Oncology Updates at a Glance

30/10/2025

Lantheus received FDA PDUFA Date for LNTH-2501 (Ga 68 edotreotide), a PET Diagnostic Imaging Kit (Ref)

The US FDA established a PDUFA date for Lantheus Holdings' LNTH-2501 (Gallium-68 edotreotide) diagnostic kit indicated for use with PET imaging for localization of SSTR+ neuroendocrine tumors in adult and pediatric patients.

• The FDA has set a PDUFA target action date of March 29, 2026

  
  

• Brian Markison, CEO, Lantheus: “The development of LNTH-2501 underscores our commitment to expanding access to high-quality diagnostic solutions in oncology. LNTH-2501 has the potential to provide clinicians a reliable and accessible option for identifying and managing somatostatin receptor-positive neuroendocrine tumors, ultimately supporting more informed treatment decisions and improved patient care.”