Adverse Events

During the long-term follow-up, only serious adverse events (SAEs) deemed related to treatment with LUTATHERA and AEs of special interest (hematotoxicity, cardiovascular events, and nephrotoxicity, regardless of causality) in the LUTATHERA arm were reported¹

Grade ≥3 Treatment-Related SAEs During the Entire Study

7 (6%) of 111 patients treated in the LUTATHERA arm¹

Incidence of Treatment-Related SAEs During the Long-Term Follow-Up Period

3 (3%) of 111 patients treated with LUTATHERA¹
— 2 (1.8%) patients experienced at least 1 grade ≥3 SAE (1 grade 5 MDS event)¹
— 1 (0.9%) patient experienced an SAE leading to study discontinuation¹

MDS or Acute Leukemia

No new cases were reported during long-term follow-up¹
— MDS incidence from the Prescribing Information for LUTATHERA:
In NETTER-1, with a median follow-up time of 76 months in the main study, MDS was reported in 2.3% of patients receiving LUTATHERA with long-acting octreotide compared with no patients receiving high-dose, long-acting octreotide^1,2
— In ERASMUS, 16 patients (2.0%) developed MDS and 4 (0.5%) developed acute leukemia. The median time to onset was 29 months (range, 9-45 months) for MDS and 55 months (range, 32-125 months) for acute leukemia^2,a

Diffuse Large B-Cell Lymphoma

One patient developed diffuse large B-cell lymphoma during long-term follow-up that was deemed unrelated to treatment with LUTATHERA¹

Nephrotoxicity of Grade ≥3, Regardless of Causality

Reported in 6 (5%) of 111 patients in the LUTATHERA arm and 4 (4%) of 112 patients in the control arm during the study¹