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spectrum pharmaceuticals inc (SPPI) Key Developments

Spectrum Pharmaceuticals, Inc. Presents at RBC Capital Markets Healthcare Conference 2015, Feb-24-2015 09:30 AM

Spectrum Pharmaceuticals, Inc. Presents at RBC Capital Markets Healthcare Conference 2015, Feb-24-2015 09:30 AM. Venue: The New York Palace Hotel, New York, New York, United States. Speakers: Rajesh C. Shrotriya, Chairman, Chief Executive Officer, Chairman of Product Acquisition Committee and Chairman of Placement Committee.

Spectrum Pharmaceuticals Announces Favorable Results from AHCT Study

Spectrum Pharmaceuticals has announced results of a clinical study of Propylene Glycol, or PG,-Free, Captisol-enabled Melphalan, or CE Melphalan, conditioning for autologous hematopoietic stem cell transplantation, or AHCT, in patients with multiple myeloma, or MM. The company filed a New Drug Application for approval of CE-Melphalan in December 2014 and expects a decision from the Food and Drug Administration by late 2015.

Spectrum Pharmaceuticals, Inc. Submits New Drug Application for Multiple Myeloma Drug to FDA

Spectrum Pharmaceuticals, Inc. has submitted a new drug application, or NDA, to the FDA for the approval of Captisol-Enabled Melphalan, or CE-Melphalan, HCl for injection 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. 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. The Phase II pivotal trial evaluating CE-Melphalan was a multi-center trial evaluating safety and efficacy. The primary objective of the study was to determine the overall safety and toxicity profile in multiple myeloma patients receiving 200 mg/m2 of CE-Melphalan as myeloablative therapy prior to autologous stem cell transplantation (ASCT).

Spectrum Pharmaceuticals Files a New Drug Application with the FDA for Captisol-Enabled™ (Propylene Glycol-Free) Melphalan

Spectrum Pharmaceuticals 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. The Phase 2 pivotal trial evaluating CE-Melphalan was a multi-center trial evaluating safety and efficacy. The primary objective of the study was to determine the overall safety and toxicity profile in multiple myeloma patients receiving 200 mg/m2 of CE-Melphalan as myeloablative therapy prior to autologous stem cell transplantation (ASCT). The secondary objectives evaluated the efficacy of CE-Melphalan in this patient population as measured by Multiple Myeloma Response Rate (according to International Myeloma Working Group [IMWG] criteria), and the rates of myeloablation and engraftment. The primary as well as secondary endpoints of this Phase 2 trial were met, and a comprehensive 505(b)(2) NDA was submitted to the FDA. In a previous clinical study, CE-Melphalan met the requirements for establishment of bioequivalence to the currently approved commercial intravenous formulation of melphalan. When approved, this demonstrated bioequivalence of CE-Melphalan should facilitate the use of this new more stable, propylene glycol-free Captisol formulation of melphalan.

Spectrum Pharmaceuticals, Inc. Presents at 7th Annual 2014 Deutsche Bank BioFEST, Dec-01-2014

Spectrum Pharmaceuticals, Inc. Presents at 7th Annual 2014 Deutsche Bank BioFEST, Dec-01-2014 . Venue: Four Seasons Hotel Boston, 200 Boylston Street, Boston, MA 02116, United States. Speakers: Kurt A. Gustafson, Chief Financial Officer, Principal Accounting Officer and Executive Vice President.

 

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