Plus Therapeutics Announces Summary of FDA Meeting on Company's cGMP Manufacturing Process for Lead Drug Candidate (GlobeNewswire) - Aug 29, 2022 - "Plus Therapeutics, Inc...announced today an update following receipt of formal minutes from a Type C meeting with the U.S. Food and Drug Administration (FDA) specific to Chemistry, Manufacturing and Controls (CMC). The meeting focused on the Company's Current Good Manufacturing Practice (cGMP) clinical and commercial manufacturing process for its lead investigational targeted radiotherapeutic, BMEDA-chelated Rhenium-186 NanoLiposome (186RNL), for recurrent glioblastoma (GBM)....The FDA indicated agreement with the Company's proposed application of cGMP guidance for radiotherapeutics, small molecule drug products and liposome drug products for Plus Therapeutics' novel 186RNL in support of ongoing and future glioblastoma clinical trials, manufacturing scale up and commercialization....The Company expects that this FDA feedback will apply to 186RNL used in other clinical development programs, including leptomeningeal metastases and pediatric brain cancer."
Commercial • FDA event • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor
|