Complete Response Letter Issued for Propylene Glycol-Free Melphalan
Spectrum announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter to the New Drug Application (NDA) of Evomela (melphalan) for patients with multiple myeloma undergoing autologous stem cell transplantation (ASCT). The FDA did not identify any clinical deficiency in the company's NDA package.
Evomela has been granted Orphan Drug designation by the FDA for its use as a high-dose conditioning regimen for patients with multiple myeloma undergoing ASCT. In a Phase 2 study, Evomela has demonstrated bioequivalence to the standard melphalan formulation, Alkeran.
Evomela is a new, propylene glycol-free melphalan formulation that utilizes Captisol (cyclodextrin) technology to optimize its stability and solubility. This new formulation is designed to prevent the renal and cardiac side-effects associated with propylene glycol and extend its administration time to 5 hours.
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