FDA Approval Summary: Tarlatamab for the Treatment of Extensive-Stage Small Cell Lung Cancer.

On May 16, 2024, the FDA granted accelerated approval to tarlatamab-dlle (hereafter referred to as tarlatamab) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The approval was based on data from DeLLphi-301 (NCT05060016), an open-label, multicenter, multicohort trial involving patients with relapsed/refractory SCLC with disease progression after platinum-based chemotherapy and at least one other line of systemic therapy. Among 99 patients, the overall response rate (ORR) was 40% [95% confidence interval (CI), 31%-51%], with a median duration of response (DoR) of 9.7 months (range, 2.7-20.7+ months). The most common adverse reactions (≥20%) were cytokine release syndrome (CRS), fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, constipation, anemia, and nausea. Product labeling includes a Boxed Warning for serious or life-threatening CRS and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS).