Melphalan intravenous - Spectrum Pharmaceuticals

Drug Profile

Melphalan intravenous - Spectrum Pharmaceuticals

Alternative Names: Captisol-Enabled® melphalan; CE melphalan; CE-Melphalan HCl; EVOMELA; LGD-353; sulfobutylether β-cyclodextrin-enabled melphalan

Latest Information Update: 17 Sep 2018

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At a glance

  • Originator CyDex Pharmaceuticals
  • Developer Boston Medical Center; CASI Pharmaceuticals; Spectrum Pharmaceuticals
  • Class Amino acids; Antineoplastics; Aromatic amino acids; Myeloablative agonists; Nitrogen mustard compounds; Small molecules
  • Mechanism of Action Alkylating agents; DNA synthesis inhibitors; DNA-damage-stimulants; Immunosuppressants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Multiple myeloma
  • New Molecular Entity No

Highest Development Phases

  • Marketed Multiple myeloma
  • Phase II Amyloidosis

Most Recent Events

  • 17 Sep 2018 Spectrum Pharmaceuticals initiates a phase I trial in Multiple myeloma and Amyloidosis in USA (IV) (NCT02909036)
  • 15 May 2018 CASI anticipates feedback from Center for Drug Evaluation/China FDA for intravenous melphalan application
  • 05 Apr 2018 A review by the Expert Advisory Anti-Tumor Drugs Committee in China for melphalan intravenous injection is scheduled on 25-26th April 2018
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