CyDex set to launch CDX-353 trial for Rx of multiple myeloma

Publication
Article
Oncology NEWS InternationalOncology NEWS International Vol 18 No 9
Volume 18
Issue 9

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.

Newsletter

Stay up to date on recent advances in the multidisciplinary approach to cancer.

Recent Videos
The National ICE-T Conference may inspire future collaboration between community and academic oncologists in the management of different cancers.
Long-term toxicities like infections and secondary primary malignancies remain a concern when sequencing novel agents for those with multiple myeloma.
Management of adverse effects and access to cellular therapies among community oncologists represented key points of discussion in multiple myeloma.
“If you have a [patient in the] fourth or fifth line, [JNJ-5322] could be a valid drug of choice,” said Rakesh Popat, BSc, MBBS, MRCP, FRCPath, PhD.
Earlier treatment with daratumumab may be better tolerated for patients with pretreated MRD-negative multiple myeloma.
The trispecific antibody JNJ-5322 demonstrated superior efficacy vs approved agents in multiple myeloma in results shared at the 2025 EHA Congress.
The dual high-affinity binding observed with ISB 2001 may avoid resistance mechanisms reported with other BCMA-targeted therapies.
4 experts are featured in this series.
4 experts are featured in this series.
4 experts are featured in this series.
Related Content