FDA reduces monitoring time for Imdelltra's first two doses

The FDA has approved an update to the prescribing information for tarlatamab-dlle (Imdelltra), significantly reducing the required monitoring time for the first two doses in patients with extensive-stage small cell lung cancer (ES-SCLC).

Patients receiving the first two infusions will now be monitored for 6 to 8 hours from the start of the infusion, a reduction from the previous recommendation of 22 to 24 hours. To maintain safety, patients must undergo a follow-up assessment, including vital signs, on the day following each of these initial doses. Additionally, patients are advised to remain within one hour of an appropriate healthcare facility for 48 hours after each infusion with a caregiver present.

This change aims to reduce treatment complexity and the time patients spend in healthcare settings, particularly for the 80% to 85% of U.S. cancer patients who receive care in community oncology practices. Tarlatamab is a bispecific T-cell engager used for adults with ES-SCLC whose disease has progressed following platinum-based chemotherapy. The drug carries a boxed warning for cytokine release syndrome (CRS) and neurologic toxicity.