The US FDA has granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen) for extensive-stage small cell lung cancer (SCLC) that has progressed after platinum-based chemotherapy. Tarlatamab is a first-in-class bispecific T-cell engager that activates T-cells and targets DLL3-expressing cells. Approval was based on data from the DeLLphi-301 trial, showing an overall response rate of 40% and a median duration of response of 9.7 months. Common adverse events include cytokine release syndrome and neurologic toxicity. Continued approval may depend on verification of clinical benefit in a confirmatory trial. The starting dose is 1 mg intravenously on day 1, followed by 10 mg on days 8 and 15 of the first cycle.
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FDA Approves Tarlatamab for Extensive-Stage SCLC
