FDA Cuts Monitoring Time for Amgen Lung Cancer Drug IMDELLTRA
The US FDA has approved an update to the prescribing information for Amgen's lung cancer drug IMDELLTRA (tarlatamab-dlle). This change reduces the recommended monitoring time for the first two doses of treatment from 22-24 hours to 6-8 hours. Patients receiving IMDELLTRA should now be monitored for 6-8 hours from the start of their first two infusions, with a follow-up assessment including vital signs the day after each dose.
IMDELLTRA is indicated for the treatment of adult patients with extensive-stage small cell lung cancer that has progressed on or after platinum-based chemotherapy. The drug works by targeting DLL3 on tumor cells and CD3 on T cells, binding to both to stimulate an immune response against cancer cells.
The updated monitoring requirement applies only to the first two doses administered in Cycle 1 Day 1 and Cycle 1 Day 8. For subsequent doses, monitoring recommendations 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 beyond.