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    Association details:
    Biomarker:SSTR positive
    Cancer:Neuroendocrine Tumor
    Drug:Lutathera (lutetium Lu 177 dotatate) (Beta radiation emitter, SSTR2 modulator)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    GlobeNewswire
    Title:

    Novartis radioligand therapy Lutathera® FDA approved as first medicine specifically for pediatric patients with gastroenteropancreatic neuroendocrine tumors

    Published date:
    04/23/2024
    Excerpt:
    Novartis...announced that the U.S. Food and Drug Administration (FDA) approved Lutathera® (USAN: lutetium Lu 177 dotatate / INN: lutetium (177Lu) oxodotreotide) for the treatment of pediatric patients 12 years and older with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Novartis Press Release
    Title:

    Novartis radioligand therapy Lutathera® demonstrated statistically significant and clinically meaningful progression-free survival in first line advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

    Published date:
    09/25/2023
    Excerpt:
    Novartis announced the Phase III NETTER-2 trial with Lutathera® (INN: lutetium (177Lu) oxodotreotide / USAN: lutetium Lu 177 dotatate) met its primary endpoint. First line treatment with Lutathera in combination with long-acting octreotide demonstrated a significant improvement in progression-free survival (PFS) in patients with newly diagnosed somatostatin receptor (SSTR)-positive...
    Secondary therapy:
    octreotide
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ESMO-GI 2021
    Title:

    O-2 Overall survival and long-term safety data from the NETTER-1 trial: 177-Lu-Dotatate vs. high-dose octreotide in patients with progressive midgut NETs

    Published date:
    07/04/2021
    Excerpt:
    ...in patients with advanced, progressive, well-differentiated, somatostatin receptor-positive midgut neuroendocrine tumors (NETs)….Median OS was 11.7 months longer with 177Lu-DOTATATE compared to high-dose octreotide in the NETTER-1 trial (48 vs. 36.3 months).
    DOI:
    https://doi.org/10.1016/j.annonc.2021.05.006
    Trial ID:
    NETTER-1
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ASCO 2021
    Title:

    Final overall survival in the phase 3 NETTER-1 study of lutetium-177-DOTATATE in patients with midgut neuroendocrine tumors.

    Published date:
    05/19/2021
    Excerpt:
    Median OS was 48.0 months in the 177Lu-DOTATATE arm of the NETTER-1 trial and 36.3 months in the control arm. This difference was not statistically significant, potentially impacted by a high rate (36%) of cross-over of patients in the control arm to radioligand therapy after progression. In overall conclusion, the NETTER-1 study demonstrated that 177Lu-DOTATATE yielded a clinically and statistically significant improvement in PFS as a primary endpoint (HR: 0.18, p< 0.0001) as well as a clinically meaningful trend towards improvement in median OS of 11.7 months.
    DOI:
    10.1200/JCO.2021.39.15_suppl.4112
    Trial ID:
    NETTER-1
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Italian Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Lutathera Treatment in GEP-NETs

    Excerpt:
    ...- Patients must be diagnosed with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic-neuroendocrine tumour (GEP-NET)....
    Trial ID:
    REAL-LU
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Post-Authorization Long-Term Safety Study of LUTATHERA

    Excerpt:
    ...- with unresectable or metastatic, well-differentiated, somatostatin receptor positive GEP-NETs...
    Trial ID:
    SALUS
    More C2 evidence