FDA declines to approve Spectrum’s Evomela injection to treat multiple myeloma

The company received a complete response letter, which the FDA sends to a company to inform that the marketing application will not be approved in its existing form.

Spectrum said the FDA did not identify any clinical deficiency in its application.

Spectrum Pharmaceuticals chairman and CEO Rajesh Shrotriya said: "We will work swiftly with the FDA to address the Complete Response Letter.

"We remain committed to bringing EVOMELA to the market for patients and plan to work closely with the FDA."

Spectrum gained development and commercialization rights to Evomela from Ligand Pharmaceuticals in March 2013. The company filed a marketing application for the drug in December last year.

Spectrum took over responsibility to complete the pivotal Phase 2 clinical trial and submit the new drug application.

Ligand received a license fee and is also eligible to receive milestone payments, as well as royalties after potential commercialization.

Evomela is a new, propylene glycol-free melphalan formulation that showed bioequivalence to the standard melphalan formulation (Alkeran) in a Phase 2 clinical study.

The FDA grated orphan drug designation to Evomela for its use as a high-dose conditioning regimen for patients with MM undergoing ASCT.

Evomela’s formulation removes the need to use a propylene glycol featuring custom diluent, which is required with other intravenous melphalan formulations. It has been reported to cause renal and cardiac side effects.