February 8, 2013 – Pomalidomide Now Approved by the FDA to Treat Multiple Myeloma under the FDA’s accelerated approval program. Pomalidomide therapy was also granted orphan product designation as it is intended to treat a rare disease. Marketed as Pomalyst by Celgene, Pomalidomide, CAS 19171-19-8, is a last chance treatment for patients with Multiple Myeloma who have not found success with other therapies. As a form of blood cancer Multiple Myeloma affects close to 22,000 Americans annually, with almost half of the patients dying from this virulent disease. Data demonstrated from a study of 221 patients with advanced stages of Multiple Myeloma proved that pomalidomide was both safe and efficacious at aiding the immune systems of patients to inhibit and even destroy the cancer cells. The patients in this study had received at least two prior therapies which included either bortezomib or lenalidomide, and unfortunately demonstrated disease progression within two months completion of their last therapy. Patients under age 18 have not been approved by the FDA to take pomalidomide. Adults who receive pomalidomide may experience low white blood cells, red blood cells and platelet counts. Blood counts of patients should be checked weekly for the initial several months of treatment to insure a transfusion is not needed. Side effects that are common include nausea, fever, back pain, diarrhea and shortness of breath, although these tend to be mild.
The breaking news of the approval of Pomalidomide for Multiple Myeloma by the FDA is a lifeline for many patients who have tried several current therapies without success. The financial future of pomalidomide looks bright, as Celgene plans to double sales to $12 billion by 2017. The market for multiple melanoma drugs are being forecast to grow 6o percent by 2021. As the third drug in a class of immunomodulatory agents alongside lenalidomide and thalidomide, pomalidomide is an effectual, tolerable and easy to administer pill.
LGM Pharma provides the API pomalidomide for research and development purposes, and provides our clients continued support throughout their entire development process.
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