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# Amgen Files Priority BLA for Lung Cancer
- URL: https://www.fdaweb.com/amgen-files-priority-bla-for-lung-cancer/
- Published: 2023-12-13T12:00:00.000Z
- Updated: 2026-09-14T14:18:30.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5155988

FDA has accepted for priority review an Amgen BLA for tarlatamab for treating adult patients with advanced small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. The agency has set a review action target date of 6/12/2024.

The BLA is based on data from the Phase 2 DeLLphi-301 clinical trial that studied patients with advanced SCLC with disease progression on or after platinum-based chemotherapy. The data “demonstrated antitumor activity with a durable response and encouraging survival outcomes in previously treated SCLC,” Amgen says, adding that the safety profile was consistent with that observed in an earlier Phase 1 trial.

Tarlatamab is described as a potential first-in-class, investigational delta-like ligand 3 (DLL3) targeting Bispecific T-cell Engager (BiTE) therapy. The BiTE technology is a “targeted immuno-oncology platform that is designed to engage a patient’s own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer,” Amgen says. “The BiTE immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens.”