Spectrum Says FDA Accepts NDA For CE-Melphalan

(RTTNews) - Spectrum Pharmaceuticals (SPPI), a biotechnology company focusing on Hematology and Oncology, said its New Drug Application for Captisol-Enabled Melphalan or CE-Melphalan, has been accepted by the U.S. Food and Drug Administration.

The FDA has assigned a Prescription Drug User Fee Act action date of October 23 for the CE-Melphalan NDA, which is 10 months from the filing date.

Spectrum is seeking FDA approval for its use as a high-dose conditioning treatment prior to autologous hematopoietic stem cell transplantation in patients with multiple myeloma, an orphan drug designation.

The company is also seeking approval for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.