BeyondSpring says FDA grants Fast Track designation for plinabulin-docetaxel Phase 3 DUBLIN-4 NSCLC trial

By Public Technologies
  • BeyondSpring won FDA Fast Track status for plinabulin with docetaxel in later-line advanced non-squamous NSCLC without actionable genomic alterations.
  • The designation supports its ongoing global Phase 3 DUBLIN-4 study, which is designed to test whether the regimen can extend survival.
  • No clinical results were presented; the next readout is planned at an interim analysis tied to disease-progression events.
  • A China-focused deal shifts funding for about half of the trial’s 442 planned patients to an outside investor, reducing cash needs.


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