Spectrum submits new drug application to FDA for CE-Melphalan

The company has filed an application for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma.

In addition, the company is seeking approval for CE-Melphalan for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.

Spectrum Pharmaceuticals chairman and CEO Rajesh Shrotriya said: "We believe the lack of propylene glycol in the preparation of CE-Melphalan eliminates the risk of the toxicities associated with that excipient.

"The improved solubility and stability of this novel melphalan formulation, CE-Melphalan, will make it an attractive treatment option for both transplant conditioning, and the palliative treatment of patients with multiple myeloma who cannot take oral melphalan."

According to the company, the Phase II study evaluating CE-Melphalan was a multi-center trial assessing safety and efficacy, and the primary objective was to determine the overall safety and toxicity profile in multiple myeloma patients receiving 200 mg/m2 of the drug as myeloablative therapy prior to autologous stem cell transplantation (ASCT).

In earlier trial, CE-Melphalan reached the requirements for establishment of bioequivalence to the currently approved commercial intravenous formulation of melphalan.

In March 2013, Spectrum obtained global development and commercialization rights to CE-Melphalan from Ligand Pharmaceuticals.

As part of the deal, Ligand secured a license fee and is also eligible to receive milestone payments, as well as royalties following potential commercialization.

Image: Histopathological image of multiple myoloma. Photo: courtesy of KGH.