Plus Therapeutics Announces Read Out of Type B Meeting with the FDA with Goal of Accelerating Approval of REYOBIQ for Leptomeningeal Metastases (GlobeNewswire) - Jan 8, 2026 - "Plus intends to incorporate the FDA's feedback in the current dose optimization trial and seek alignment with the FDA on a revised protocol, likely later this year....FDA indicated that accelerated approval may be appropriate for the LM indication, but there are insufficient data to support the use of circulating tumor cells (CTCs) as an intermediate clinical endpoint....FDA recommended that the study evaluate an endpoint with established clinical benefit, such as overall survival, while encouraging further study of patient reported outcomes and neurologic function as endpoints that could potentially support a marketing application."
Clinical protocol • FDA event • Brain Cancer • CNS Tumor
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