FDA official announcements or healthcare regulatory news

Amgen Receives Accelerated FDA Approval for New Lung Cancer Drug Imdelltra

May 16, 2024, 07:45 PM

Amgen has received accelerated approval from the U.S. Food and Drug Administration (FDA) on Thursday for its new drug, Imdelltra (tarlatamab), designed to treat adult patients with advanced small cell lung cancer (SCLC). This approval is specifically for patients whose disease has progressed despite chemotherapy. Imdelltra is a DLL3-targeting bispecific T-cell engager and represents a significant advancement in the treatment of this aggressive and most deadly form of lung cancer.