FDA Fast Track Designation for Plinabulin in Post-ICI Non-Squamous NSCLC
“We believe the FDA Fast Track designation, an FDA-aligned global Phase 3 strategy, and funding to support China-generated clinical data would meaningfully strengthen our ability to advance Plinabulin and DUBLIN-4 toward the trial’s next major clinical milestone—the prespecified interim analysis at 221 PFS events,” said Min Qiu, CEO of BeyondSpring. “Fast Track designation underscores the significant unmet medical need for the DUBLIN-4 patient population in NSCLC patients whose disease has progressed following ICI and without AGAs, with limited options and docetaxel as the standard of care. Importantly, the strategic transaction provides a time- and capital-efficient approach to executing our global Phase 3 clinical strategy. Positive results from the interim analysis could represent a meaningful value inflection point for BeyondSpring.”
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