Melphalan Captisol filed with FDA for Multiple Myeloma-Spectrum Pharma
Spectrum Pharmaceuticals filed a New Drug Application with the FDA for Melphalan Captisol (captisol-enabled melphalan) for injection (propylene glycol-free), for use as a high-dose conditioning treatment prior to stem cell transplantation in Multiple Myeloma and for the palliative treatment of patients with Multiple Myeloma for whom oral therapy is not appropriate. Spectrum is also seeking approval for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. The Phase II pivotal trial evaluating CE-Melphalan was a multi-center trial evaluating safety and efficacy. The primary as well as secondary endpoints of this trial were met.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
3 mins