FDA Cuts Monitoring Time for Tarlatamab Doses in Small Cell Lung Cancer
The US FDA has approved an update to the prescribing information for tarlatamab-dlle (Imdelltra) that reduces the recommended monitoring time for the first two doses of treatment in patients with extensive-stage small cell lung cancer (ES-SCLC).
According to a news release from Amgen, the new recommendation is for 6 to 8 hours of monitoring after each of the first two infusions, compared to the previous 22 to 24 hours. A follow-up assessment will also be conducted on the day following each dose.
The update aims to reduce the time patients spend in a healthcare setting during the initial treatment period and simplify care for community oncology practices, which account for an estimated 80-85% of US cancer patients' care.
David M. Waterhouse, MD, MPH, FASCO, a medical oncologist/hematologist at Oncology Hematology Care in Cincinnati, Ohio, stated that reducing the monitoring period may make tarlatamab more feasible to administer in community practices and help more patients receive treatment in their local care network.