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 to improve its stability. This allows for slower infusion rates and longer administration times for during conditioning prior to stem cell transplant and reduces the risk of propylene glycol-associated renal and cardiac side-effects. The company said it was working closely with the FDA to address the Complete Response Letter.


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