FDA Sets PDUFA Date for LNTH-2501 in Imaging of SSTR+ Neuroendocrine Tumors

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2026, for LNTH-2501 (gallium-68 edotreotide), a diagnostic kit for the preparation of gallium-68 edotreotide injection, designed for use in PET imaging for localization of somatostatin receptor (SSTR)–positive neuroendocrine tumors (NETs) in adult and pediatric patients.1

“The development of LNTH-2501 underscores our commitment to expanding access to high-quality diagnostic solutions in oncology,” Brian Markison, chief executive officer of Lantheus Holdings, stated in a news release. “LNTH-2501 has the potential to provide clinicians a reliable and accessible option for identifying and managing SSTR-positive NETs, ultimately supporting more informed treatment decisions and improved patient care.”

Evidence supporting the diagnostic performance of gallium-68 edotreotide was evaluated in 2 prospective clinical trials evaluating its accuracy in identifying somatostatin receptor–positive (SSTR+) NETs.2

The first study (NCT01619865) was designed to evaluate the efficacy of gallium-68 edotreotide PET/CT for the diagnosis, staging, and treatment response assessment of SSTR-positive NETs.3 The trial aimed to compare this PET/CT modality with standard-of-care Octreoscan SPECT combined with high-resolution, contrast-enhanced CT to determine its relative diagnostic performance. Key objectives included assessing the sensitivity of gallium-68 edotreotide PET/CT in detecting SSTR-positive NETs and evaluating its ability to measure treatment response in patients who had undergone recent interventions such as surgery, chemotherapy, targeted therapy, or peptide receptor radionuclide therapy.

The study evaluated 177 patients with known or suspected SSTR-positive neuroendocrine tumors (NETs), gallium-68 edotreotide PET/CT demonstrated strong diagnostic concordance with reference standards.2 Reader 1 identified 121 true positives and 39 true negatives, yielding positive and negative agreement rates of 91% (95% CI, 85%-95%) and 89% (95% CI, 75%-96%), respectively. Reader 2 produced similar findings, with 120 true positives and 38 true negatives, corresponding to 90% (95% CI, 84%-95%) positive and 86% (95% CI, 73%-95%) negative agreement.

The second study, a phase 2 trial (NCT01869725), was designed to compare the diagnostic accuracy of gallium-68 edotreotide PET/CT with standard indium 111-pentetreotide (Octreoscan) imaging combined with contrast-enhanced CT or MRI in patients with SSTR–expressing tumors.4 Patients received intravenous gallium-68 edotreotide followed by PET/CT scanning. Within 120 days, they underwent Octreoscan with high-resolution, contrast-enhanced CT or MRI for diagnostic comparison. A second PET/CT scan was permitted within 3 to 6 months if initial findings required confirmation.

The study enrolled 62 patients with histologically confirmed NETs or other SSTR-positive tumors who were undergoing disease evaluation before or after treatment.2 Of these, 59 patients had sufficient data for efficacy assessment per the composite reference standard.

Results demonstrated strong diagnostic agreement between gallium Ga 68-edotreotide PET/CT and the reference standard, with positive and negative percent agreements of 92% and 75%, respectively, for reader 1, and 90% and 75% for reader 2.

References

1. Lantheus announces FDA grants PDUFA date for LNTH-2501 (Ga 68 edotreotide), a PET diagnostic imaging kit targeting somatostatin receptor-positive (SSTR+) neuroendocrine tumors (NETs). Lantheus Holdings, Inc. News Release. October 30, 2025. Accessed October 30, 2025. https://lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-announces-fda-grants-pdufa-date-lnth-2501-ga-68
2. Prescribing information for GALLIUM Ga 68 EDOTREOTIDE§ INJECTION. US FDA. Updated July 2023. Accessed October 30, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210828s003lbl.pdf
3. Safety of 68Ga-DOTA-tyr3-octreotide PET in diagnosis of solid tumors (GA-68). ClinicalTrials.gov. Updated July 27, 2021. Accessed October 30, 2025. https://clinicaltrials.gov/study/NCT01619865
4. Comparative study of sensitivity of Ga-DOTATOC PET vs octreoscan SPECT + CT. ClinicalTrials.gov. Updated September 22, 2021. Accessed October 30, 2025. https://clinicaltrials.gov/study/NCT01869725