Spectrum Pharma Submits NDA For CE-Melphalan - Quick Facts

(RTTNews) - Spectrum Pharmaceuticals Inc. (SPPI) announced the company has submitted a New Drug Application (NDA) to the U.S. 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. The company is also seeking approval for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.

Spectrum Pharma expects FDA review to take approximately 10 months. The company said it plans to launch the drug with existing hematology/oncology sales force next year pending approval.

Spectrum Pharma gained global development and commercialization rights to CE-Melphalan from Ligand Pharmaceuticals Incorporated (LGND) in March 2013. Spectrum assumed the responsibility for the pivotal clinical trial and was responsible for filing the NDA. Under the license agreement, Ligand received a license fee and is eligible to receive milestone payments, as well as royalties following potential commercialization.