The new formulation goes by the brand name "Evomela". It also is sometimes described as "Captisol-enabled melphalan". The formulation does not include propylene glycol, a chemical that has been reported to have heart- and kidney-related side effects. The Captisol technology also improves the stability of Evomela's melphalan formulation. Together, the improved stability and lack of propylene glycol may allow Evomela to be administered at doses higher than can be safely achieved with currently available melphalan formulations.
Captisol technology also is used in the formulation of other intravenously administered drugs, including Kyprolis (carfilzomib).
Right now, the only information that is available about the approval of Evomela is what the FDA-approved uses of the drug will be. These are as follows:
- High-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma.
- Palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
The prescribing information for Evomela is not yet available, so we do not yet know what the approved dose of Evomela melphalan will be. Also, neither the FDA nor Spectrum Pharmaceuticals have issued a press release about the FDA approval.
In a bit of a surprise last fall, the FDA initially declined to approve Evomela, as we reported in this earlier forum thread, "FDA declines to approve new IV melphalan formulation" (Oct 23, 2015). The company subsequently resubmitted the new drug application (NDA) for Evomela, which led to the new approval decision.
The new approval decision came much earlier than the FDA's deadline for deciding on the second new drug application, which was May 9, 2016. This suggests Spectrum was quite effective in addressing whatever concerns caused the FDA to initially decline to approve Evomela.
