FDA Cuts Monitoring Time for Amgen's IMDELLTRA Treatment

The US FDA has approved an update to the prescribing information for Amgen's IMDELLTRA (tarlatamab-dlle) treatment, reducing the recommended monitoring time for the first two doses from 22-24 hours to 6-8 hours in an appropriate healthcare setting.

Patients receiving IMDELLTRA will be monitored for 6-8 hours from the start of their first two infusions and will receive a follow-up assessment, including vital signs, the day after each of these initial doses. This change could mean less time spent in a healthcare setting during the initial treatment period for people living with extensive-stage small cell lung cancer (ES-SCLC).

According to Amgen's executive vice president Jay Bradner, M.D., 'People being treated for small cell lung cancer are already navigating an aggressive and difficult-to-treat disease, and the time required to receive and monitor treatment can add to that burden.'