NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Approved 10 months from the first CHM meeting!
The approval is based on findings from the phase 2 DeLLphi-301 study (NCT05060016).
DeLLphi-301 [NCT05060016], an open-label, multicenter, multi-cohort study, did not include a comparative placebo arm.
This product (Tarlatamab) was submitted and approved via a national procedure as part of Project ORBIS.

On May 16, 2024, the Food and Drug Administration granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy