The approval was granted under the FDA's accelerated approval pathway, and continued approval will depend on further verification of clinical benefits in additional trials.
Imdelltra's approval is based on results from the phase 2 DeLLphi-301 clinical trial, which reported a 40% objective response rate, a median duration of response of 9.7 months, and a median overall survival of 14.3 months among patients. The drug works by targeting DLL3, a protein expressed on the surface of SCLC cells, and activating T-cells to attack these tumor cells.
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.