Skip to Content

Evomela Approval History

Evomela (melphalan) is an alkylating agent used as a high-dose conditioning treatment prior to stem cell transplantation in patients with multiple myeloma (MM), and for the palliative treatment of patients with MM for whom oral therapy is not appropriate.

FDA approval of Evomela was based on its bioequivalence to the standard melphalan formulation (Alkeran) in a Phase 2 clinical study. It marks the first new formulation of melphalan developed since its initial approval in 1964.

Conventional formulations of melphalan (such as Alkeran) have marginal solubility, limited chemical stability and require propylene glycol as a co-solvent, which is associated with renal dysfunction and arrhythmias. Evomela is a propylene glycol-free formulation of melphalan that incorporates Captisol® technology to improve solubility, stability, and bioavailability. Evomela is stable for four hours at room temperature, and after reconstitution with normal saline, is stable for one hour at room temperature and 24 hours at refrigerated temperature (5°C).

Development History and FDA Approval Process for Evomela

Mar 15, 2016Approval FDA Grants Spectrum Pharmaceuticals Approval of Evomela (melphalan) for Injection

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.