Amgen Lung Cancer Treatment Gets Easier with FDA Monitoring Update

Amgen has announced that the FDA has approved an update to the prescribing information for its lung cancer treatment, IMDELLTRA (tarlatamab-dlle). The updated guidelines reduce the recommended monitoring time for the first two doses of treatment. Patients receiving IMDELLTRA should now be monitored for 6 to 8 hours from the start of their first two infusions, compared with the previously recommended 22 to 24 hours.

Patients will also receive a follow-up assessment, including vital signs, the day after each of these first two doses. IMDELLTRA is indicated for the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.

The updated monitoring requirement applies only to the first two doses administered on Cycle 1 Day 1 and Cycle 1 Day 8. Monitoring recommendations for subsequent doses remain unchanged, ranging from 6-8 hours for the third dose through Cycle 2, decreasing to 3-4 hours for Cycles 3-4 and 2 hours for Cycle 5 and subsequent doses.