Misty Shields, Assistant Professor at Indiana University School of Medicine, shared on LinkedIn:
“Amgen Oncology received approval on September 14, 2026 to REDUCE the recommended monitoring period for tarlatamab, which is currently FDA approved for the 2L setting for ES-SCLC.
Specifically, this approved label update reduces the recommended monitoring for cycle 1 day 1 and day 8 of tarlatamab:
- observation 22-24 hrs – 6-8 hrs
- vital signs & assessment follow up on the subsequent day (days 2 and 9)
Note: Patients should remain within 1 hr of the appropriate healthcare setting for 48 hrs, following cycle 1 day 1 and day 8, and care partner support is encouraged.
These vital updates help our SMASHERS gain improved access to life-changing therapeutics by reducing barriers, such as need for hospitalization for administration and monitoring.
Unmet need: Validated risk assessment tools will be helpful to identify those who may be at risk for high grade CRS and early interventions.”
This also can be interesting:
DeLLphi-305: Durvalumab + Tarlatamab Improves Survival in First-Line ES-SCLC
