U.S. FDA Approved New Injection of Melphalan Congener for Two Indications in Multiple Myeloma
Evomela–Captisol-enabled melphalan procured U.S. FDA approval for two indications in multiple myeloma, with which it became the first drug to secure U.S. FDA approval for high-dose conditioning indication in multiple myeloma.
A new injection (EVOMELA HCl), Melphalan congener for multiple myeloma is ready to come to the market as it has received U.S. FDA approval. The whole credits goes to Evomela owner, Spectrum Pharmaceuticals which is a biotechnology company chiefly involved in drug development and commercialization with major focus on hematology and oncology.
First indication is the high dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation (HSCT) and the second one as palliative treatment for those myeloma patients who are not receiving oral therapy. The FDA approval for the two indications was based on the multicenter, open-label, phase 2b study on 61 enrolled patients.
Multiple myeloma is a kind of blood cancer in which the plasma cells becomes abnormal or cancerous. Plasma cells are normal constituents of white blood cells (WBCs), mainly involved in antibody production. When these plasma cells become cancerous they get accumulated in bone marrow and in turn alter the haematopoiesis. Due to immunodeficiency the person becomes weak. According to an article published in New England Journal of Medicine, the optimum treatment for multiple myeloma is consolidation therapy with high dose melphalan along with stem cell transplantation followed by maintenance therapy.
Spectrum Pharmaceuticals claim that their product EVOMELA is propylene free normal saline formulation that uses Captisol technology, which allow the formulation to maintain its stability even at room temperature for a period of about four hours.
Interestingly, EVOMELA will be the sixth successful haematology/oncology product of Spectrum Pharmaceuticals in U.S. In March 2013, Spectrum Pharmaceutical received international development and commercialization rights for EVOMELA from Ligand Pharmaceuticals. In December 2014, it filed a marketing application for the drug. Spectrum gained a Complete Response Letter (CRL) from U.S. FDA indicating disapproval for their application, however FDA failed to provide any clinical deficiency in that application. After this the company amended its application in November, 2015 but again they failed to get FDA approval. Finally the company got FDA approval for EVOMELA in 2016.
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