A Phase IIA Open-Label, Randomized, Pharmacokinetic Comparative, Cross-Over Study of Melphalan HCL for Injection (Propylene Glycol-Free) and Alkeran for Injection for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation
Phase of Trial: Phase II
Latest Information Update: 15 Mar 2016
At a glance
- Drugs Melphalan (Primary)
- Indications Multiple myeloma
- Focus Pharmacokinetics; Registrational
- Sponsors Spectrum Pharmaceuticals
- 15 Mar 2016 According to a Spectrum Pharmaceuticals media release, EVOMELA was approved by the FDA based on its bioequivalence to the standard melphalan formulation (Alkeran) via the 505(b)(2) regulatory pathway.
- 15 Mar 2016 According to a Ligand Pharmaceuticals media release, based on the results of this trial, company has received approval from the U.S. Food and Drug Administration (FDA) of melphalan (EVOMELA) for use in two indications: 1) as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation (ASCT) in patients with multiple myeloma, and 2) for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
- 23 Oct 2015 According to a Spectrum Pharmaceuticals media release, the company has received a Complete Response Letter from the U.S. FDA for propylene glycol-free melphalan formulation [Evomela]. The FDA has not identified any clinical deficiency in Spectrum's NDA submission and the company plans to meet with the FDA and seek clarification on the Complete Response Letter.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History