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FDA Approves Imdelltra (tarlatamab-dlle) for Extensive Stage Small Cell Lung Cancer

May 17, 2024

On May 16, 2024, the U.S. Food and Drug Administration (FDA) granted Imdelltra (tarlatamab-dlle) accelerated approval for people with extensive stage small cell lung cancer (ES-SCLC) following progression on or after platinum-based chemotherapy.The approval is based on results from the DeLLphi-301 trial (NCT05060016). Participants with relapsed or progressive ES-SCLC after receiving platinum-based chemotherapy were given Imdelltra (tarlatamab-dlle) as follow-up therapy. Results showed that people receiving Imdelltra (tarlatamab-dlle) generally experienced some benefit from receiving therapy. Participants also saw the effects of those benefits for a meaningful period of time over several months. People who receive this drug should closely monitor side effects with their healthcare team, as some study participants experienced serious side effects.Imdelltra (tarlatamab-dlle) is a new type of treatment for ES-SCLC known as a bi-specific T-cell engager. This type of therapy helps a person’s immune system identify and attack cancer cells in the body by binding to targets on both T-cells (a type of immune cell in the body) and the cancer itself. Imdelltra (tarlatamab-dlle) targets a protein on the surface of T-cells known as CD3 and a protein found on the surface of cancer cells known as DLL3, which is found in over 85% of people with SCLC. This exciting approval offers an entirely new type of treatment—and hope—for people living with ES-SCLC.Read the full FDA announcement here.

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