CyDex set to launch CDX-353 trial for Rx of multiple myeloma
The FDA has accepted an Investigational New Drug (IND) application from CyDex Pharmaceuticals for a clinical study of Captisol-enabled melphalan HCL (CDX-353).
The FDA has accepted an Investigational New Drug (IND) application from CyDex Pharmaceuticals for a clinical study of Captisol-enabled melphalan HCL (CDX-353). Melphalan (Alkeran) is an FDA-approved low-dose chemotherapy for multiple myeloma marketed by GlaxoSmithKline. A phase II(a) trial that compares the pharmacokinetics and safety of CDX-353 with Alkeran is planned. Alkeran is packaged as two vials that must be combined prior to injection and requires immediate administration. CDX-353 is a one-vial formulation that remains stable at room temperature for an extended period of time, according to CyDex.
FDA Approves Cilta-Cel for Relapsed/Refractory Myeloma After 1 Therapy
April 6th 2024The FDA has approved ciltacabtagene autoleucel for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least 1 prior line of treatment, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.
Relapsed/Refractory Multiple Myeloma Trial Updates From ASCO 2023
August 7th 2023Experts from Mayo Clinic and The University of Texas MD Anderson Cancer Center discuss results from multiple myeloma trials presented at the 2023 American Society of Clinical Oncology Annual Meeting and how they may apply to clinical practice.
