Amgen updates IMDELLTRA label via BLA supplement; registers romosozumab bioavailability trial
Amgen secured approval of a labeling supplement for IMDELLTRA and posted a new Phase 1 trial comparing romosozumab injection methods.
Amgen had two regulatory and clinical trial updates this week.
- Amgen's IMDELLTRA (AMG757), tarlatamab-dlle, received approval for a labeling supplement (submission 2) under BLA761344, with the approval dated September 15, 2026.1
- Amgen registered a new Phase 1 trial for romosozumab (AMG 785), also marketed as Evenity, in healthy participants. The study is designed to evaluate the relative bioavailability of romosozumab administered as a single 2.34 mL subcutaneous injection from a prefilled syringe or as 2 x 1.17 mL SC injections from a prefilled syringe.2 The trial has not yet begun recruiting, with an estimated start date of September 22, 2026, and estimated primary completion on January 14, 2027.2 Planned enrollment is 308 participants.2
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