Spectrum prepares NDA as late-stage pipeline pumps out promise
By Marie Powers
Thursday, April 24, 2014
Spectrum Pharmaceuticals Inc. looked toward another win in its late-stage pipeline as Captisol-enabled (propylene glycol-free) melphalan met the primary endpoints in a pivotal phase II safety and efficacy study. The company plans to file a new drug application (NDA) in the third quarter under the 505(b)(2) pathway for the high-dose intravenous formulation of CE melphalan as a conditioning treatment in autologous stem cell transplantation (ASCT) in multiple myeloma.
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