FDA Cuts Monitoring Time for Tarlatamab-Dllle's First Two Doses

The FDA has approved an update to the labeling of Imdelltra (tarlatamab-dlle), reducing the post-infusion monitoring period for the first two doses in patients with extensive-stage small cell lung cancer (ES-SCLC) from 22 to 24 hours to 6 to 8 hours.

This change is intended to simplify care for people living with and treating ES-SCLC, according to Jay Bradner, MD, executive vice president of research and development, AI, and data at Amgen. 'People being treated for SCLC are already navigating an aggressive and difficult-to-treat disease, and the time required to receive and monitor treatment can add to that burden for both patients and care centers.'

Tarlatamab-dlle was granted full approval by the FDA in November 2025 for the treatment of adult patients with ES-SCLC who have progressed on or following platinum-based chemotherapy. The approval is based on data from the phase 3 DeLLphi-304 trial, which showed that tarlatamab-dlle produced a median overall survival of 13.6 months compared to 8.3 months for chemotherapy.

The safety profile of tarlatamab-dlle includes any-grade cytokine release syndrome (CRS) in 57% of patients and neurologic toxicity, including immune effector cell, associated neurotoxicity syndrome (ICANS), in 65% of patients.