FDA Approves 2 New Indications for Multiple Myeloma Drug

Evomela is the first drug approved for a high-dose conditioning indication of multiple myeloma.

The FDA has approved Spectrum Pharmaceuticals’ melphalan (Evomela) for 2 new indications for patients with multiple myeloma.

Now, Evomela may be used as a high-dose conditioning treatment prior to hematopoietic progenitor cell transplantation in patients with multiple myeloma and for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. This marks the first product to be FDA-approved for a high-dose conditioning indication for multiple myeloma.

The treatment does not contain propylene glycol, and its admixture solution remains stable for 4 hours at room temperature in addition to the 1-hour following reconstitution.

"The approval of Evomela marks the first new formulation of melphalan approved by the FDA since its initial approval in 1964," said Parameswaran Hari, Armand J. Quick/William F. Stapp professor of hematology at the Medical College of Wisconsin, in a press release. "Melphalan is extensively used in the treatment of multiple myeloma and is the main drug in conditioning therapy pre-transplant.”

The most common adverse effects include decreased neutrophil count, decreased white blood cell count, fatigue, diarrhea, and nausea.