LNTH-2501 (gallium Ga 68 edotreotide)
PET imaging of somatostatin receptor-positive neuroendocrine tumors · Patients being evaluated for somatostatin receptor-positive neuroendocrine tumors
LNTH · Lantheus Holdings, Inc.
Full timeline
3 milestonesFDA issued a Complete Response Letter
FDA said unresolved inspection-related conditions at the third-party drug-product manufacturing facility prevented approval. Lantheus did not report clinical efficacy or safety deficiencies.
Lantheus — LNTH-2501 Complete Response Letter↗FDA extended the review by three months
FDA moved the PDUFA date from March 29 to June 29, 2026 to review additional manufacturing-related information; the extension was not related to efficacy or safety data.
Lantheus — First-quarter 2026 report and LNTH-2501 review extension↗FDA accepted the LNTH-2501 NDA
FDA accepted the application and initially assigned a March 29, 2026 PDUFA target action date.
Lantheus — Form 10-Q and LNTH-2501 regulatory history↗Related News
No related news available.