AMGN · News · 20260914N

Regulatory Approval Milestones

AMGEN INC · 2026-09-14 · Importance 31 · Surprise 42

The FDA approved an update to IMDELLTRA (tarlatamab-dlle) labeling on September 14, 2026. The update substantially reduces the recommended monitoring time for the first two doses in an appropriate healthcare setting. The change is intended to support broader access to IMDELLTRA in community settings for patients with extensive-stage small cell lung cancer.

Key facts

• Amgen maintains a massive, diversified portfolio of medicines serving approximately 17 million patients globally. source