The US FDA issued an approvable letter to Celgene Corporation in response to its sNDA for multiple myeloma (MM). The FDA has requested revised product labelling with the specific indication of newly diagnosed multiple myeloma and updated safety information, as well as some additional patient information to finalize its review.
The Thalomid sNDA is based on results from a large Phase III randomized Eastern Cooperative Oncology Group (ECOG) study comparing thalidomide plus dexamethasone to dexamethasone alone in previously untreated multiple myeloma patients.
"Based on ongoing discussions with the FDA we expect to complete our responses to these requests quickly," said Graham Burton, Regulatory Affairs and Pharmacovigilance for Celgene.
Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Multiple myeloma is the second most common cancer of the blood, representing approximately one percent of all cancers and two percent of all cancer deaths with a reported worldwide prevalence of approximately 200,000 cases. In the year 2004, there were an estimated 74,000 new cases of multiple myeloma worldwide. The estimated number of deaths from multiple myeloma in 2005 is about 60,000 worldwide.
Thalomid (thalidomide), manufactured by Celgene Corporation, received US FDA clearance on July 16, 1998 for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence.