The European Medicines Agency has been informed by Celgene Europe Limited that it has withdrawn its submission for approval for Revlimid (lenalidomide) – an application for an extension of the therapeutic indication in newly diagnosed multiple myeloma (blood cancer) patients, as well as new pack sizes had been sought.
Business analysts say this is a setback for Celgene Europe’s best-selling medication, which was expected to grow.
In December 2010, Celgene Europe Limited applied for a variation of the marketing authorization for lenalidomide so that it could be indicated for maintenance treatment of patients newly diagnosed with multiple myeloma who had not progressed after initial treatment with prednisone, melphalan and Revlimid, or following autologous stem cell transplantation.
According to Robert J. Hugin, Celgene pulled its application after talks with CMPH (EU’s Committee for Medicinal Products for Human Use) during which they had asked for more mature data on the benefits and harms of the medication.
Revlimid is already approved on both sides of the Atlantic for the treatment of multiple myeloma in combination with dexamethasone, but only for patients who had received at least one prior therapy.. The company wanted authorization for their drug as a maintenance therapy earlier on during the disease.
For this new indication, the company had applied for two new strengths and new 7-capsule packs, on top of the existing 5mg, 10mg, and 15 mg strengths.
Celgene says it will continue applying for new indications in Australia, Switzerland and some other countries. The company added that it plans to apply to the Food and Drug Administration (FDA), USA, next year after re-evaluating its submission.
Multiple myeloma, also known as plasma cell myeloma, or just myeloma is cancer of the plasma cells – a type of white blood cell which exists in the bone marrow. Plasma cells make immunoglobulin (antibodies) which help fight off infections.
Myeloma cells (a group of abnormal cells) multiply, raising the number of plasma cells excessively, resulting in abnormally high levels of immunoglobulin. Multiple myeloma affects red blood cell count, the kidneys, the immune system, and the bones.
The ACS (American Cancer Society) says that multiple myeloma has a lifetime risk of 1 in 161 (0.61%), making it a relatively uncommon cancer. There are approximately 20,000 new cases each year in the USA, and nearly 4,000 in the UK. Multiple myeloma represents about 1% of all cancers among US Caucasians, and 2% of African-Americans.
Written by Christian Nordqvist