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News
The FDA has granted fast track designation to plinabulin plus docetaxel for advanced nonsquamous non-small cell lung cancer (NSCLC) in patients whose disease progressed after immunotherapy and platinum-based chemo. The combo showed a median overall survival of 15.8 months vs. 11.7 months with docetaxel alone in a phase 3 post-hoc analysis. It also significantly reduced severe neutropenia, a common chemo side effect.
The FDA has granted fast track designation to plinabulin combined with docetaxel for patients with advanced or metastatic nonsquamous NSCLC who lack actionable genomic alterations and whose disease has progressed after both immunotherapy (anti–PD-(L)1) and platinum-based chemotherapy. This is a notoriously difficult-to-treat population with limited options beyond docetaxel as the standard of care.
Plinabulin is a first-in-class, brain-penetrating small molecule that works by promoting dendritic cell maturation — helping to restore immune function after resistance to checkpoint inhibitors develops. It also reduces chemotherapy-induced neutropenia, potentially making docetaxel more tolerable. The designation is backed by data from the phase 3 DUBLIN-3 trial and prospective Study 303, and is intended to accelerate the ongoing global phase 3 DUBLIN-4 trial (442 patients planned), which aims to support a future new drug application.
By the Numbers
Why it matters: With ~60% of NSCLC patients eventually developing resistance to immunotherapy and no new approvals in this post-ICI setting, plinabulin's fast track status signals real momentum toward filling a critical treatment gap.
