Amgen's Lung Cancer Drug Gets FDA Monitoring Time Cut

Amgen has announced that the US Food and Drug Administration (FDA) has approved an update to the prescribing information for its lung cancer drug, IMDELLTRA. The updated guidelines reduce the recommended monitoring time for the first two doses of treatment from 22-24 hours to 6-8 hours.

Patients receiving IMDELLTRA should be monitored for 6-8 hours from the start of their first two infusions and receive a follow-up assessment, including vital signs, the day after each of these first two doses. This change applies only to the first two doses administered on Cycle 1 Day 1 and Cycle 1 Day 8.

IMDELLTRA is indicated for the treatment of adult patients with extensive-stage small cell lung cancer that has progressed after platinum-based chemotherapy. The drug is a targeted immunotherapy engineered to bind to both DLL3 on tumor cells and CD3 on T cells.