Import Approval Granted for Rare Small Cell Lung Cancer Drug "Imdeltaraju"

First Approval in Korea for Third-Line Treatment by the Ministry of Food and Drug Safety

The Ministry of Food and Drug Safety announced on May 30 that it has approved the import of the rare drug "Imdeltaraju 1mg·10mg" (active ingredient: Talatamab).

Imdeltaraju is an anticancer drug used to treat adult patients with relapsed or refractory extensive-stage small cell lung cancer who have previously received at least two lines of therapy, including platinum-based chemotherapy. It is the first drug to be approved in Korea as a third-line treatment for this indication.

Small cell lung cancer is a disease characterized by small cancer cells that primarily develop in the central airways of the lungs, accounting for 15 to 25 percent of all diagnosed lung cancers.

Imdeltaraju works by simultaneously binding to the DLL3 (Delta-like ligand 3) protein expressed on the surface of lung cancer cells and to CD3 expressed on the surface of T cells (as a bispecific antibody), thereby activating T cells and inducing the destruction of DLL3-expressing lung cancer cells.

The Ministry stated, "In January of last year, this drug was designated as the 25th product under the Global Innovative Product Fast Track (GIFT) program and was reviewed rapidly to ensure its swift introduction into the Korean healthcare system," adding, "We expect that it will provide new treatment opportunities for patients with small cell lung cancer."