On May 16, 2024, the US Food and Drug Administration (FDA) announced the accelerated approval of tarlatamab-dlle (Imdelltra®) to treat patients with extensive-stage small cell lung cancer (SCLC).
This targeted immunotherapy, the first of its kind, is based on new technology. Tarlatamab is a bispecific T-cell engager (BiTE)—a drug with two arms that simultaneously binds to a T cell (a part of the immune system) and a tumor cell. This allows the T cell to come close enough to the tumor cell to recognize and destroy it.
Tarlatamab is a second-line treatment that can be considered if chemotherapy is no longer effective.
It is available to patients through the FDA’s accelerated approval process, which hurries exciting treatments to patients who need them. Accelerated approvals can be controversial because there is less scientific rigor required and the overall effectiveness of the treatments is still being studied.
For more details, including possible serious immune-related side effects, please see the FDA press release.
You can find additional information about this FDA approval in the newsfeed on this website.