FDA rejects new drug application for use of captisol-enabled melphalan in myeloma

Spectrum Pharmaceuticals, the US commercial-based biotechnology company, has announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter declining the approval of its drug captisol-enabled melphalan (Evomela™) in its current form for use as a treatment for myeloma patients. Evomela is a propylene glycol-free formulation which uses Captisol® technology to reformulate melphalan…

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