On November 19, 2025, the FDA approved a supplemental application for tarlatamab, also known as Imdelltra (tarlatamab-dlle), a drug sponsored by Amgen Inc. This approval specifically addresses the efficacy of the drug, as indicated by the supplemental application BLA 761344 S-1.
Background
Tarlatamab, known by its brand name Imdelltra and also identified as AMG757, is a pharmaceutical product developed by Amgen Inc. The FDA's action on November 19, 2025, involves a supplemental application for this drug, with the specific focus being its efficacy.
What this means
The approval of a supplemental application for efficacy by the FDA represents a significant regulatory update for tarlatamab (Imdelltra). This indicates that the agency has reviewed new data or information submitted by Amgen Inc. and found it sufficient to support an update to the drug's label or approved uses based on its demonstrated effectiveness. Such an approval can potentially expand the patient population for whom the drug is indicated, refine dosing instructions, or highlight additional benefits, thereby impacting clinical practice and patient access to this therapy. The 'major' importance assigned to this event underscores its potential impact within the therapeutic landscape.
Source
The information regarding this FDA approval was obtained from the official FDA website, specifically the Drugs@FDA database. The supplemental application for BLA 761344 was approved on November 19, 2025, as detailed on accessdata.fda.gov.