AMGN · News · 20260914N
IMDELLTRA Regulatory Approval Milestones
AMGEN INC · 2026-09-14 · Importance 31 · Surprise 42 · In source text
On September 14, 2026, the U.S. Food and Drug Administration approved an update to Amgen’s IMDELLTRA (tarlatamab-dlle) Prescribing Information. The update substantially reduces the recommended monitoring time for the first two doses when administered 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. Separate reporting described the approval as streamlining treatment administration, but did not quantify a revenue or cost impact.
Key facts
- On Sept. 14, 2026, Amgen announced that the U.S. Food and Drug Administration (FDA) approved an update to the IMDELLTRA® (tarlatamab-dlle) Prescribing Information that substantially reduces the recommended monitoring time for the first two doses of treatment in an appropriate healthcare setting. source
- Amgen has received FDA approval to reduce the monitoring time required for the first two doses of its drug Imdelltra. source
- The approved update to IMDELLTRA's prescribing information "supports broader access to IMDELLTRA in community settings for people living with extensive-stage small cell lung cancer." source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | committed | — | On Sept. 14, 2026, Amgen announced that the U.S. Food and Drug Administration (FDA) approved an update to the IMDELLTRA® (tarlatamab-dlle)… |
| operating_income | positive | committed | — | On Sept. 14, 2026, Amgen announced that the U.S. Food and Drug Administration (FDA) approved an update to the IMDELLTRA® (tarlatamab-dlle)… |