The U.S. Food and Drug Administration (FDA) has granted approval of Evomela for use in two indications: 1) use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation (ASCT) in patients with multiple myeloma (MM), and 2) for the palliative treatment of patients with MM for whom oral therapy is not appropriate. This is the first product to be FDA-approved for the high-dose conditioning indication in MM.
“I am very proud to announce that Spectrum has been able to bring another new cancer drug to the market,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “This represents the commercialization of our sixth Hematology/Oncology product in the U.S. 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. We are very excited about the approval of Evomela as this fits seamlessly into our existing commercial infrastructure. In addition to our five other currently marketed products, we believe revenues from Evomela will help us expeditiously develop the potential blockbusters that we have in our late-stage pipeline.”
“The approval of Evomela marks the first new formulation of melphalan approved by the FDA, since its initial approval in 1964,” said Dr. Parameswaran Hari, Armand J. Quick/William F. Stapp Professor of Hematology at the Medical College of Wisconsin, Director of the Adult Blood and Marrow Transplant Program at Froedtert Hospital and the Section Head of Hematologic Malignancies and Transplantation, in the Division of Hematology and Oncology in the Department of Medicine.
“Melphalan is extensively used in the treatment of multiple myeloma and is the main drug in conditioning therapy pre-transplant. Evomela's new formulation does not contain propylene glycol and is stable for 4 hours at room temperature in addition to the 1 hour following reconstitution.”
About Multiple Myeloma
Multiple Myeloma is a systemic malignancy of plasma cells that accumulate in the bone marrow, usually associated with monoclonal antibody secretion, and results in bone marrow failure and bone destruction. It is the second most common hematologic disease with nearly 30,000 new cases projected in the US in 2016 and over 11,000 deaths annually (American Cancer Society Stats, 2016). The rate of ASCT for patients with MM is growing by approximately 3.3% annually.
Melphalan is the most commonly used IV agent for high-dose conditioning for patients undergoing ASCT for MM. The current IV melphalan market is approximately $100 million annually, with predominant use in ASCT; Evomela is the only intravenous melphalan product that is approved for use in the high-dose conditioning indication. About Evomela
Evomela was approved by FDA based on its bioequivalence to the standard melphalan formulation (Alkeran) in a Phase 2 clinical study (Aljitawi et al, Bone Marrow Transplant, 2014) via the 505(b)(2) regulatory pathway. Evomela has been granted Orphan Drug Designation by the FDA for its use as a high-dose conditioning regimen for patients with MM undergoing ASCT. Evomela's new melphalan formulation does not contain propylene glycol. The use of the Captisol® technology to reformulate also contributes to the 4-hour admixture stability of Evomela at room temperature. This is in addition to the 1 hour stability of reconstituted Evomela drug product at room temperature and 24 hour stability at refrigerated temperature (5°C).
Source: drugs.com