[Beacon Staff]

New Drug Application filed for new form of melphalan

by Beacon Staff on Sat Dec 27, 2014 2:13 am

Spectrum Pharmaceuticals has filed a new drug application with the U.S. Food and Drug Administration (FDA), asking that it be allowed to market a new form of melphalan for use during the high-dose chemotherapy phase of stem cell transplants for multiple myeloma patients.

As described in a set of Beacon Newsflashes earlier this year,

The new formulation of melphalan, which Spectrum calls "Captisol-enabled melphalan", does not include propylene glycol, a chemical that has been reported to have heart- and kidney-related side effects. The Captisol technology also improves the stability of Spec­trum's melphalan formulation. Together, the improved stability and lack of propylene glycol may allow Spec­trum's formulation to be administered at doses higher than can be safely achieved with currently available mel­pha­lan formulations. Captisol technology also is used in the formulation of Kyprolis (car­filz­o­mib)."

A decision on the new drug application can be expected in the second half of 2015.

A press release about the application, which was announced yesterday, can be found at The Beacon here:

"Spectrum Pharmaceuticals Files A New Drug Application With The FDA For Captisol-Enabled™ (Propylene Glycol-Free) Melphalan," Spectrum Pharmaceuticals press release, Dec 26, 2014.

[Beacon Staff]

Re: New Drug Application filed for new form of melphalan

by Beacon Staff on Tue Mar 10, 2015 12:09 pm

Spectrum Phar­ma­ceu­ti­cals provided an update yes­ter­day on the progress of its ap­pli­ca­tion to have its new form of melphalan approved by the FDA. The FDA has accepted the application requesting approval of the drug, and a decision on the application is expected by this October.

Here's a press release with Spectrum's update:

"Spectrum Pharmaceuticals Announces FDA's Acceptance Of NDA Filing For Captisol-Enabled™ (Propylene Glycol-Free) Melphalan," Spectrum Pharmaceuticals press release, March 9, 2015.

Here's an excerpt from the press release:

Spectrum Pharmaceuticals ... today announced that its New Drug Application (NDA) for Captisol-Enabled Melphalan (CE-Melphalan), has been accepted by the U.S. Food and Drug Administration (FDA). The FDA has assigned [an] action date of October 23, 2015 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 (progenitor) stem cell transplantation (AHCT) in patients with multiple myeloma (multiple myeloma), an orphan drug designation. Spectrum is also seeking approval for the palliative treatment of pa­tients with multiple myeloma for whom oral therapy is not appropriate."