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.