The US Food and Drug Administration approved an update to tarlatamab-dlle (IMDELLTRA) prescribing information that reduces recommended monitoring following the first 2 doses in patients with extensive-stage small cell lung cancer, according to an Amgen press release.

Patients should now be monitored in an appropriate health care setting for 6 to 8 hours from the start of the first 2 infusions, compared with the previously recommended 22 to 24 hours. The updated prescribing information also calls for an assessment, including vital signs, the day following each of the first 2 doses.

The revised monitoring period applies only to the first 2 doses. Recommended monitoring remains 6 to 8 hours following the third dose on cycle 1, day 15 and throughout cycle 2. The recommended period decreases to 3 to 4 hours during cycles 3 and 4 and to 2 hours during cycle 5 and subsequent doses.

Following doses on cycle 1, days 1 and 8, patients should remain within 1 hour of an appropriate health care setting for 48 hours from the start of infusion and be accompanied by a caregiver. Tarlatamab is administered as a 1-hour intravenous infusion using a step-up dosing schedule.

Tarlatamab is indicated in adult patients with extensive-stage small cell lung cancer with disease progression on or following platinum-based chemotherapy. The targeted immunotherapy binds DLL3 on tumor cells and CD3 on T cells, activating T cells to target DLL3–expressing small cell lung cancer cells.

Tarlatamab carries boxed warnings for cytokine release syndrome and neurologic toxicity, including immune effector cell–associated neurotoxicity syndrome. In a pooled safety population of 473 patients, cytokine release syndrome occurred in 57%, including grade 3 events in approximately 2% and grade 4 events in less than 1%. Among 268 patients who experienced cytokine release syndrome, 73% had an event following the first dose and 60% following the second dose.

Neurologic toxicity occurred in 65% of patients, including grade 3 or higher events in 7%. Additional warnings and precautions include cytopenias, infections, hepatotoxicity, hypersensitivity reactions, and embryo-fetal toxicity.

Source: Amgen