FDA press releases or official announcements

Amgen's Imdelltra Receives Accelerated FDA Approval for Most Deadly Form of Lung Cancer in Landmark Decision

May 16, 2024, 08:06 PM

Amgen has received accelerated approval from the U.S. Food and Drug Administration (FDA) for its new drug, Imdelltra (tarlatamab), designed to treat adult patients with advanced small cell lung cancer (SCLC). This approval is significant as it targets a particularly aggressive and most deadly form of lung cancer that has worsened despite chemotherapy. Imdelltra is a DLL3-targeting bispecific T-cell engager and is the first BiTE® therapy for extensive-stage small cell lung cancer (ES-SCLC). The FDA approval, noted on the FDA website, is considered a landmark achievement in the evolution of small cell lung cancer care. The drug has shown promise in clinical trials by reducing tumor growth and extending patients' lives. It comes with a boxed warning for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). It is to be used only by patients who have exhausted all other options and have a life expectancy of four to five months.