Spectrum Pharmaceuticals announced that FDA has approved Evomela for 2 indications related to multiple myeloma. This is the first product to be FDA-approved for the high-dose conditioning indication in MM.

Indications: 1. Use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation (ASCT) in patients with multiple myeloma (MM); 2. For the palliative treatment of patients with MM for whom oral therapy is not appropriate.

Adverse reactions: The most common adverse reactions observed in at least 50% of patients with multiple myeloma treated with Evomela were neutrophil count decreased, white blood cell count decreased, lymphocyte count decreased, platelet count decreased, diarrhea, nausea, fatigue, hypokalemia, anemia, and vomiting.

In a single-arm clinical study, 12 (20%) patients with multiple myeloma who received Evomela conditioning for ASCT experienced a treatment emergent serious adverse reaction. The most common serious adverse reactions were pyrexia, hematochezia, febrile neutropenia, and renal failure.

In a randomized clinical trial studying the palliative treatment of patients with multiple myeloma, severe myelotoxicity was more common in the IV melphalan arm (28%) than in the oral melphalan arm (11%).

Citation: FDA grants Spectrum Pharmaceuticals approval of EVOMELA™ (melphalan) for injection. [news release]. Henderson, NV: Spectrum Pharmaceuticals; March 15, 2016. http://investor.sppirx.com/releasedetail.cfm?ReleaseID=960622. Accessed March 15, 2016.