Celgene Corporation (CELG)

[jimmybob]

Celgene Revlimid approved by EC
Celgene International Sàrl, a wholly owned subsidiary of Celgene, announced that the European Commission, or EC, has approved Revlimid for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. The Revlimid Marketing Authorisation has been updated to include this new indication in multiple myeloma, building upon the already approved indication of Revlimid in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Multiple myeloma is a persistent and life-threatening blood cancer that is characterised by tumour proliferation and suppression of the immune system. It is a rare but deadly disease: around 38,900 people were newly diagnosed with multiple myeloma in Europe in 2012, and 24,300 people died from the disease in the same year. On average, multiple myeloma is diagnosed in people 65-74 years of age, and the majority of newly diagnosed patients may not be eligible for more aggressive treatment options such as high-dose chemotherapy with stem cell transplant. The EC decision in newly diagnosed multiple myeloma was based on the results of two pivotal studies: MM-020 and MM-015