Is Imdelltra (Tarlatamab-dlle) on the market?

On May 16, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Imdelltra (Tarlatamab-dlle) produced by Amgen (AMGN), a targeted immunotherapy for adults with advanced refractory small cell lung cancer whose disease continues to progress despite chemotherapy. The drug, marketed as Imdelltra, is part of a pipeline of bispecific antibodies designed to attach to cancer cells and immune cells, bringing them together so the body's immune system can kill the cancer.

The FDA's accelerated approval of Imdelltra is based on results from the Phase 2 DeLLphi-301 clinical trial, which evaluated Imdelltra in patients with SCLC who had failed two or more prior therapies and received a 10 mg every two weeks (Q2W) dosing regimen. The study results found that the 10 mg Q2W dose of Imdelltra (N=99) showed a robust objective response rate (ORR) of 40% (95% confidence interval [CI]: 31-51) and a median DoR of 9.7 months (95% CI, 2.7, 20.7+). The median overall survival (mOS) was 14.3 months. Final and complete survival data are not yet mature.

Lung cancer is a complex and extremely devastating disease, with less than3% of ES-SCLC patients surviving for more than 5 years. FDA approval of Imdelltra marks a critical moment for patients battling ES-SCLC. This DLL3-targeted therapy in ES-SCLC includes a transformative option that demonstrates long-term responses in pre-treated patients. These responses were remarkably durable and represent a major advance in the treatment paradigm for small cell lung cancer. This approval further demonstrates the potential to address aggressive cancers with the second FDA-approved bispecific T-cell engager (BiTE) molecule.