FDA revises monitoring for SCLC therapy

Initial monitoring decreases from 22 to 24 hours to 6 to 8 hours from the start of the first 2 infusions.

Category	Detail
Condition	Extensive-stage small cell lung cancer
Key Mechanisms	Tarlatamab binds DLL3 on tumor cells and CD3 on T cells, activating T cells to target DLL3-expressing small cell lung cancer cells.
Target Population	Adult patients with extensive-stage small cell lung cancer with disease progression on or following platinum-based chemotherapy.
Care Setting	Health care setting for monitoring after tarlatamab infusions.

Monitoring reduced from 22-24 hours to 6-8 hours after the first 2 doses.
Assessment of vital signs required the day after each of the first 2 doses.
Monitoring periods decrease with subsequent cycles: 3-4 hours for cycles 3 and 4, 2 hours for cycle 5 and beyond.
Cytokine release syndrome occurred in 57% of patients, with 2% experiencing grade 3 events.
Neurologic toxicity occurred in 65% of patients, with 7% experiencing grade 3 or higher events.

Monitor patients for 6-8 hours after the first 2 doses of tarlatamab.
Patients should remain within 1 hour of a health care setting for 48 hours after doses on cycle 1, days 1 and 8.

Cytokine release syndrome, neurologic toxicity, cytopenias, infections, hepatotoxicity, hypersensitivity reactions, and embryo-fetal toxicity.

Adult patients with extensive-stage small cell lung cancer.

Tarlatamab is administered as a 1-hour intravenous infusion using a step-up dosing schedule.

Ensure appropriate monitoring in a health care setting after tarlatamab infusions.
Educate patients about the signs and symptoms of cytokine release syndrome and neurologic toxicity.