Corporate Member Update: Amgen
Corporate Member Update: Amgen
IMPORTANT UPDATE: Full FDA Approval Granted in 2L ES-SCLC
IMDELLTRA® (tarlatamab-dlle) is now fully FDA-approved for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA is the first and only DLL3-targeting Bispecific T-cell Engager (BiTE®) therapy approved in this setting, representing an important milestone for patients and providers.
This approval was based on results from the Phase 3 DeLLphi-304 trial, which was a phase 3, multicenter, randomized, open-label trial evaluating the efficacy and safety of IMDELLTRA® compared with chemotherapy in 509 patients with ES-SCLC who had progressed after treatment with 1 prior line of platinum-containing chemotherapy, with or without a PD-(L)1 inhibitor. Patients were randomized 1:1 to receive IMDELLTRA® (n=254) or chemotherapy (n=255).
The study demonstrated a median OS of 13.6 months with IMDELLTRA® compared to 8.3 months with chemotherapy, with a 40% reduction in the risk of death (HR 0.60; p<0.001).1,2
The most common (> 20%) adverse reactions in clinical trials of IMDELLTRA(R) were CRS (57%), fatigue (48%), decreased appetite (38%), dysgeusia (34%), pyrexia (33%), constipation (31%), musculoskeletal pain (31%), and nausea (25%).2
Please see the Indication and Important Safety Information below, including the Boxed Warnings, as well as the full Prescribing Information.
You can learn more at IMDELLTRAhcp.com.
