Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) announced that FDA had approved EVOMELA for commercial use. As per the reports, pursuant to this approval, EVOMELA can be used in two conditions: 1) for those patients suffering from (multiple myeloma ) MM and can’t be treated with oral therapy and require palliative treatment. (2) Using a high-dose of EVOMELA before hematopoietic progenitor cell transplantation in those patients who have MM.
Insights of Matter
The senior management team of Spectrum is delighted to get the FDA approval and hopes that things will continue to roll in company’s direction in the coming months as well. According to Rajesh C. Shrotriya, CEO, Chairman & MD, Spectrum, it’s a proud moment for the company as it has just launched another cancer drug in the market. It’s the sixth time when the company has launched a Hematology/Oncology product in the United States market.
Spectrum has formulated EVOMELA in such a way that it doesn’t make any room for propylene glycol and is admixed and reconstituted with normal saline. The new formulation is equipped with the renowned Captisol technology, which enables the admixture solution to remain stable in room temperature for up to 4 hours after one hour of reconstitution. The technology has already been used in many other FDA approved drugs with 100% positive user feedback.
With this approval, EVOMELA has made it to company’s product portfolio that’s ready to be commercialized all across the globe. Spectrum has 5 products up and running in the market, with the inclusion of EVOMELA, it will be able to generate extra revenue that will help it expand in different markets and work on many more such quality products in the coming months.
It’s the first occasion since the year 1964 when a new melphalan formulation has been granted approval. Going forward, Spectrum will try its best to live up to customers and stakeholders expectations by delivering quality products and services.