IMDELLTRA
Q2 2026 sales more than doubled to $288 million, up 115%; the European Commission approved it in May 2026.
The numbers
What it is
T-cell engager for small cell lung cancer. It is one of Amgen's newest oncology products and is growing fast from a small base.
Why it matters to the stock. IMDELLTRA is Amgen's main growth hope in oncology. Further data from DeLLphi-309 could expand its use.
News
FDA cuts IMDELLTRA first-dose monitoring window to 6 to 8 hours from 22 to 24 hours
The FDA approved a label update on September 14, 2026 that shortens the observation period after the first two IMDELLTRA infusions to 6 to 8 hours, down from 22 to 24 hours.
IMDELLTRA plus Imfinzi improves overall survival in first-line small cell lung cancer
Amgen said on September 8, 2026 that the Phase 3 DeLLphi-305 trial met its primary endpoint at a pre-specified interim analysis.
Amgen's 2026 outlook: $38.2B to $39.4B revenue and $22.30 to $23.50 non-GAAP EPS
Alongside its second-quarter results, Amgen set full-year 2026 guidance of $38.2 billion to $39.4 billion in total revenues, non-GAAP diluted EPS of $22.30 to $23.50, and GAAP diluted EPS of $15.80 to $17.08.
European Commission approves IMDYLLTRA for small cell lung cancer after platinum therapy
The European Commission granted marketing authorization for IMDYLLTRA (tarlatamab) as monotherapy for adults with extensive-stage small cell lung cancer whose disease progressed on or after platinum-based chemotherapy.