Approvals

This accelerated approval follows a positive response rate and duration of response (DoR) observed in the drug’s clinical trials. This includes results from the phase 2 DeLLphi-301 trial, which assessed the drug in patients with SCLC who had failed two or more prior lines of therapy. Results saw that a 10mg dose of Imdelltra had an objective response rate (ORR) of 40% and a median DoR of 9.7 months, with a median overall survival (mOS) of 14.3 months. Final and complete survival data is not yet mature for this trial.

Continued approval for this indication is likely to be dependent on verification and description of its clinical benefit through a confirmatory clinical trial.

Jay Bradner MD, executive vice president of Research and Development, and chief scientific officer at Amgen, commented: “The FDA's approval of Imdelltra marks a pivotal moment for patients battling ES-SCLC. This DLL3-targeting therapy in ES-SCLC comprises a transformative option demonstrating long-lasting responses in pretreated patients. This approval further demonstrates our commitment to addressing aggressive cancers through our second FDA-approved Bispecific T-cell Engager (BiTE) molecule. Imdelltra offers these patients who are in urgent need of new innovative therapies hope, and we're proud to deliver this long-awaited effective treatment to them.”

Laurie Fenton Ambrose, co-founder, president, and CEO of GO2 for Lung Cancer, added: “After decades of minimal advancements in the SCLC treatment landscape, there is now an effective and innovative treatment option available. Today's FDA approval marks a significant milestone for the SCLC community as the availability of a targeted bispecific therapy brings forward new possibilities to those living with this aggressive disease.”