FDA approves Amgen’s Tarlatamab

On 16 May 2024, the FDA granted accelerated approval to Amgen’s IMDELLTRATM (tarlatamab-dlle) for small cell lung cancer that has progressed on or after platinum-based chemotherapy.  Tarlatamab is a Bispecific T-cell Engager (BiTE®) molecule designed to engage a patient’s own T cells to attack DLL3-expressing tumour cells. 

The FDA granted priority review to Amgen’s tarlatamab BLA in December 2023.