BeyondSpring says FDA grants Fast Track designation for plinabulin-docetaxel Phase 3 DUBLIN-4 NSCLC trial
BYSI•BeyondSpring said the FDA granted Fast Track designation to plinabulin with docetaxel for later-line advanced non-squamous NSCLC; its global Phase 3 trial plans to enroll 442 patients, with no clinical results presented.
1. Trial designation
The designation supports the ongoing global Phase 3 DUBLIN-4 study, designed to test whether the regimen can extend survival in patients without actionable genomic alterations. 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.
