Early this morning, Spectrum Pharmaceuticals announced they received a Complete Response Letter from the FDA regarding their New Drug Application (NDA) for Evomela (propylene glycol (PG)-free IV formulation of melphalan).
A Complete Response Letter means the FDA will not review the drug for approval based on current information in the NDA. It does not mean the drug is ineffective or unsafe –it just means that more information is needed in the NDA for the FDA to review the application.
Details of what was written in the Complete Response Letter are currently unknown but said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals said,
“We will work swiftly with the FDA to address the Complete Response Letter. ” Dr Shrotriya added, “We remain committed to bringing EVOMELA to the market for patients and plan to work closely with the FDA.”
Spectrum Pharmaceuticals obtained Evomela from Ligand Pharmaceuticals in March 2013 and had assumed responsibility for completing the pivotal Phase 2 clinical trial for filing the NDA at that time.
Melphalan inhibits DNA replication and transcription causing cytotoxicity in dividing and non-dividing cells including multiple myeloma. Evomela is a new propylene glycol (PG)-free IV formulation of melphalan developed for patients with multiple myeloma undergoing HSCT. The formulation completely avoids the use of PG, which is used as a co-solvent in the current formulation of melphalan.
In December 2014, Spectrum submitted an NDA for the approval of Evomela as a high-dose conditioning treatment prior to ASCT in patients with multiple myeloma. Spectrum is sought approval for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
The PDUFA date was October 23, 2015.
Multiple myeloma is a hematologic cancer caused by the production and growth of abnormal cells within the plasma, which multiply and build up in the bone marrow. Multiple myeloma is an incurable disease with a high rate of relapse (cancer returns) and patients often become refractory (unresponsive to therapy), despite currently available treatments.
Spectrum Pharmaceuticals Receives Complete Response Letter (CRL) from U.S. Food and Drug Administration (FDA) for EVOMELA™ (melphalan) for Injection [News release]. Enderson, NV. Spectrum Pharmaceuticals; October 23, 2015. http://www.businesswire.com/news/home/20151022006757/en/Spectrum-Pharmaceuticals-Receives-Complete-Response-Letter-CRL