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news.The US Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals' Evomela (melphalan) for high-dose conditioning treatment for multiple myeloma (MM) patients undergoing an autologous stem cell transplant and for the palliative treatment of MM patients who cannot take oral therapy.
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The approval was based on its bioequivalence to the standard melphalan formulation (Alkeran) in a phase 2 clinical study.
Evomela has been granted Orphan Drug Designation by the FDA for its use as a high-dose conditioning regimen for patients with MM undergoing autologous stem cell transplantation.
Evomela’s new melphalan formulation does not contain propylene glycol.
Spectrum secured global development and commercialization rights to Evomela from Ligand Pharmaceuticals in March 2013.
The company was responsible to complete the pivotal Phase 2 clinical trial, and has also filed the NDA.
Under the license agreement, Ligand secured a license fee and is eligible to receive milestone payments, and royalties after potential commercialization.
Spectrum Pharmaceuticals Chairman and CEO Rajesh Shrotriya said: "Our Evomela formulation does not contain propylene glycol and is reconstituted and admixed with normal saline.
"This new formulation also uses Captisol technology, which allows the admixture solution to be stable for 4 hours at room temperature in addition to the 1 hour following reconstitution and has been used in several other FDA-approved products.