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.
![“Every patient [with multiple myeloma] should be offered CAR T before they’re offered a bispecific, with some rare exceptions,” said Barry Paul, MD.](/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fcancernetwork%2F70a5f0fed7009863fe30cf0740cf32014ebaf5be-2974x1660.png%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=30 "“Every patient [with multiple myeloma] should be offered CAR T before they’re offered a bispecific, with some rare exceptions,” said Barry Paul, MD.")
![“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.](/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fcancernetwork%2F267879fc15a40ec8d3ed04d8ee9c1f044b49ee89-2990x1692.png%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=30 "“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.")
Navigating AE Management for Cellular Therapy Across Hematologic Cancers
A panel of clinical pharmacists discussed strategies for mitigating toxicities across different multiple myeloma, lymphoma, and leukemia populations.
