Spectrum Pharmaceuticals, Inc. (SPPI: Quote) said Friday that it has submitted a New Drug Application or NDA to the U.S. Food and Drug Administration for approval of Captisol-Enabled Melphalan HCl for injection to be used as a high-dose conditioning treatment prior to stem cell transplantation in patients with multiple myeloma. Henderson, Nevada-based Spectrum Pharma is also seeking approval for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. The biotechnology company noted that the NDA submission represented an important step forward in bringing new treatment options to cancer patients. Spectrum Pharma expects the FDA review to take about 10 months, and plans to launch the drug with its existing hematology and oncology sales force next year pending approval. The company noted that its formulation is free of propylene glycol and does not use a custom solvent for its reconstitution. Spectrum Pharma gained global development and commercialization rights to CE-Melphalan from Ligand Pharmaceuticals Inc. (LGND: Quote) in March 2013. The company assumed the responsibility for the pivotal clinical trial and was responsible for filing the NDA for CE-Melphalan. Under the license agreement, Ligand received a license fee and is eligible to receive milestone payments, as … Continue reading
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