Plus Therapeutics Announces Read Out of Type B Meeting with the FDA with Goal of Accelerating Approval of REYOBIQ™ for Leptomeningeal Metastases

Core Insights - Plus Therapeutics, Inc. has completed a Type B meeting with the FDA regarding the pivotal trial strategy for REYOBIQ in treating leptomeningeal metastases (LM), leading to constructive discussions on study design [1][3] - The company aims to incorporate FDA feedback into its current dose optimization trial and plans to align on a revised protocol later this year, with the goal of preparing for a pivotal trial [1][3] - REYOBIQ is a novel injectable radiotherapy designed for CNS tumors, with potential advantages over existing therapies, and is currently being evaluated in multiple clinical trials [5][8] FDA Meeting Highlights - The FDA indicated that accelerated approval may be appropriate for the LM indication, but more data is needed to validate circulating tumor cells (CTCs) as a surrogate endpoint [6] - The FDA recommended evaluating endpoints with established clinical benefits, such as overall survival, while considering CTCs as a secondary endpoint [6] - A randomized controlled trial design was discussed, potentially including an intrathecal chemotherapeutic as a comparator [6] About Leptomeningeal Metastases - LM is a rare but severe complication of advanced cancer, occurring in approximately 5% of metastatic cancer patients, with a median survival of 2-6 months [4] - Common sources of LM include breast cancer, lung cancer, and melanoma, highlighting the urgent need for novel therapies [4] About REYOBIQ - REYOBIQ (rhenium Re186 obisbemeda) is formulated to deliver targeted high-dose radiation in CNS tumors, aiming to optimize patient outcomes with reduced off-target risks [5] - The product is being evaluated for recurrent glioblastoma, LM, and pediatric brain cancer in various clinical trials, supported by significant grants from the National Cancer Institute and other organizations [5] Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for challenging CNS cancers, with a pipeline that includes treatments for LM and recurrent glioblastoma [8] - The company has established a supply chain through strategic partnerships to support the development and future commercialization of its products [8]