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FDA Issues Complete Response Letter for CE-Melphalan in Myeloma

Jason M. Broderick @jasoncology
Published: Friday, Oct 23, 2015

Rajesh C. Shrotriya, MD

Rajesh C. Shrotriya, MD

The FDA issued a complete response letter to Spectrum Pharmaceuticals, informing the company that its new drug application (NDA) for the use of Captisol-enabled (CE) melphalan (Evomela) in multiple myeloma will not be approved in its current form.

Hari PN, Ajitawi O, Arce-Lara C, et al. Results of a phase ii study of propylene glycol (PG)-free, captisol-enabled melphalan conditioning for autologous hematopoietic stem cell transplantation (AHCT) in patients with multiple myeloma (MM). BBMT. 2015;21(2)(suppl):S138.

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