FDA Approves Spectrum’s Evomela

Spectrum Pharmaceuticals Inc. March 15 said the FDA has approved Evomela (melphalan hydrochloride) for two multiple myeloma indications.

The indications are for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation (ASCT) in patients with multiple myeloma (MM), and for the palliative treatment of patients with MM for whom oral therapy isn’t appropriate, the company said.

This is the first product to be approved by the Food and Drug Administration for the high-dose conditioning indication in MM, Spectrum said.

Use of 505(b)(2) Process.

Evomela was approved by the FDA based on its bioequivalence to the standard ...