The Food adn Drug Administration (FDA) granted accelerated approval to tarlatamab-dlle on May 17, 2024, offering a new treatment option for adults battling extensive-stage small cell lung cancer (SCLC). This marks a critically important advancement in addressing a particularly aggressive form of cancer with limited therapeutic choices.
SCLC accounts for approximately 10-15% of all lung cancer diagnoses, and typically spreads rapidly. The approval of tarlatamab-dlle provides a targeted therapy for patients whose cancer has progressed after platinum-based chemotherapy, a common first-line treatment. This decision is based on promising results from the Phase 3 clinical trial, published in the New England Journal of Medicine in 2025, and offers renewed hope for individuals facing this challenging diagnosis.
Tarlatamab-dlle is a bispecific antibody that targets DLL3, a protein frequently expressed in SCLC. By binding to both DLL3 on cancer cells and CD3 on immune cells, it activates the immune system to attack and destroy the tumor. Clinical trial data,as reported by Ferruggia (2024) in Pharmacy Times,demonstrated a statistically significant improvement in progression-free survival compared to standard of care chemotherapy.
The efficacy and safety of tarlatamab-dlle were evaluated in the Phase 3 trial (NCT05740566) involving patients who had experienced disease progression following initial platinum-based chemotherapy. Mountzios et al. (2025) detailed the trial findings, revealing a median progression-free survival of 4.8 months with tarlatamab-dlle versus 1.5 months with standard chemotherapy. Common side effects observed in clinical trials included peripheral neuropathy, musculoskeletal pain, and cytokine release syndrome. Continued monitoring and evaluation will be required to assess the long-term benefits and risks of this novel therapy.
