FDA issues Complete Response letter relating to Evomela (captisol-enabled melphalan) an intended treatment for multiple myeloma- Spectrum Pharma

Spectrum Pharmaceuticals has announced that it has received a Complete Response Letter from the FDA in relation to Evomela (captisol-enabled melphalan), an intended treatment for multiple myeloma. In the letter, the FDA did not identify any clinical deficiency in Spectrum's NDA package.

Comment: Evomela is a conditioning treatment for use in autologous transplant for patients with multiple myeloma and is a new IV formulation of melphalan (currently sold as Alkeran for injection). The new formulation completely avoids the use of propylene glycol, which has been used as a co-solvent in other formulations and has been reported to cause renal and cardiac side effects that limit the ability to deliver higher quantities of intended therapeutic compounds.