Tarlatamab FDA Approval Status
Last updated by Judith Stewart, BPharm on Jan 16, 2024.
FDA Approved: No
Generic name: tarlatamab
Company: Amgen Inc.
Treatment for: Small Cell Lung Cancer
Tarlatamab is a potential first-in-class, investigational delta-like ligand 3 (DLL3) targeting Bispecific T-cell Engager (BiTE®) therapy for the treatment of adult patients with advanced small cell lung cancer with disease progression on or after platinum-based chemotherapy.
- Small cell lung cancer (SCLC) is an aggressive form of lung cancer that is strongly associated with cigarette smoking.
- Tarlatamab is a targeted therapy that brings a patient's own T cells in close proximity to SCLC cells by binding both CD3 on T cells and DLL3 on SCLC cells. This results in the formation of a cytolytic synapse with lysis of the cancer cell.
- The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Biologics License Application (BLA) for tarlatamab.
- The Prescription Drug User Fee Action (PDUFA) date for tarlatamab is June 12, 2024.
Development timeline for tarlatamab
| Date | Article |
|---|---|
| Dec 13, 2023 | FDA Grants Priority Review to Amgen's Tarlatamab Application for Advanced Small Cell Lung Cancer |
| Oct 20, 2023 | Amgen Presents New Tarlatamab Data In Small Cell Lung Cancer |
Further information
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