Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, today announced the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of Captisol-Enabled Melphalan (CE-Melphalan) HCl for injection (propylene glycol-free) for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. Spectrum is also seeking approval for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.

"We believe the lack of propylene glycol in the preparation of CE-Melphalan eliminates the risk of the toxicities associated with that excipient," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "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. The enhanced stability of this new CE-Melphalan formulation simplifies clinical administration and is anticipated to allow for longer use and infusion times. This NDA submission represents another important step forward in bringing new treatment options to cancer patients."

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