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- FDA Grants Full Approval to Lung Cancer Drug Tarlatamab Based on Trial . . .
The U S Food and Drug Administration (FDA) has granted full approval to the drug tarlatamab, a bispecific T cell engager, for small cell lung cancer, based on results from a phase 3 clinical trial led by Dr Charles Rudin at MSK
- FDA grants traditional approval to tarlatamab-dlle for extensive stage
On November 19, 2025, the Food and Drug Administration granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen Inc ) for adults with extensive stage s
- Tarlatamab in Small-Cell Lung Cancer after Platinum-Based Chemotherapy
Tarlatamab, a bispecific delta-like ligand 3–directed T-cell engager immunotherapy, received accelerated approval for the treatment of patients with previously treated small-cell lung cancer
- FDA Grants Full Approval to Tarlatamab in Small Cell Lung Cancer
The FDA has granted a full approval to tarlatamab-dlle for extensive-stage small cell lung cancer
- FDA Approves Tarlatamab-Dlle to Treat Adults With Extensive Stage Small . . .
The FDA approved tarlatamab-dlle (Imdelltra; Amgen) for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy The approval is supported by positive efficacy findings from the phase 3 DeLLphi-304 (NCT05740566) clinical trial 1,2 Tarlatamab is a bispecific delta-like ligand 3-directed T-cell engager
- FDA Grants Full Approval to Amgens Imdelltra (tarlatamab-dlle) in . . .
About Imdelltra (tarlatamab-dlle) Imdelltra is a first-in-class targeted immunotherapy engineered by Amgen researchers to bind to both DLL3 on tumor cells and CD3 on T cells, thereby activating T cells to kill DLL3-expressing SCLC cells
- Imdelltra Receives Full FDA Approval as First-In-Class . . . - WebMD
Imdelltra (tarlatamab-dlle) is a first-of-its kind targeted cancer medicine called a bispecific T-cell engager approved for treating adults with extensive-stage small-cell lung cancer (ES-SCLC
- Tarlatamab-dlle - NCI - National Cancer Institute
Tarlatamab-dlle (Imdelltra) works by bringing healthy T cells (immune cells that help kill cancer cells) and lung cancer cells close together so the T cells can more effectively kill the lung cancer cells
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