Plus Therapeutics announced that it has successfully completed a Type B meeting with the U.S. Food and Drug Administration (FDA) to discuss the Company’s clinical development plans for REYOBIQ™, its targeted radiotherapeutic for leptomeningeal metastases (LM).
The meeting focused on key elements of the REYOBIQ development pathway, including the proposed design of a planned pivotal or registrational ReSPECT-LM clinical trial. This milestone marks an important step forward in establishing a viable regulatory route for a potential future treatment option for patients suffering from LM—one of the most challenging and life-threatening complications of metastatic cancer.
Read the full press release: https://lnkd.in/gqmpQEvR
Advancing a New Treatment Option for Leptomeningeal Metastases
Leptomeningeal metastases occur when cancer cells spread to the membranes surrounding the brain and spinal cord. LM is most commonly associated with breast cancer, lung cancer, melanoma, and other advanced cancers, and remains notoriously difficult to treat using traditional systemic or radiation therapies.
REYOBIQ™ (rhenium [186Re] obisbemeda) is designed to overcome these challenges through image-guided, intraventricular delivery directly into the cerebrospinal fluid (CSF), allowing therapeutic radiation to target LM tumor cells throughout the CNS compartment.
The recent FDA Type B meeting provides important regulatory clarity as Plus Therapeutics works toward initiating a pivotal clinical study intended to support potential registration.
About the ReSPECT-LM Clinical Trial
The ongoing ReSPECT-LM Phase 1/2 trial is evaluating the safety, dosing, and preliminary efficacy of REYOBIQ for patients with leptomeningeal metastases from solid tumors. The study represents one of the few interventional clinical trials in LM and has generated encouraging early data regarding feasibility, tolerability, and disease control.
Patients, caregivers, and clinicians may explore eligibility and trial details at:
respect-trials.com/lm
A Step Forward for Patients and Neuro-Oncology Innovation
Completion of the FDA Type B meeting reflects Plus Therapeutics’ continued progress in developing innovative radiotherapeutics that address significant unmet needs in neuro-oncology. As LM continues to impact thousands of patients each year, advancing new treatment options remains a critical priority.
The Company expects to provide additional updates as plans for the pivotal trial advance.
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