Janssen Biotech Inc. announced the U.S. Food and Drug Administration (FDA) has approved Sylvant (siltuximab) for the treatment of patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Sylvant was not studied in patients with MCD who are HIV positive or HHV-8 positive because Sylvant did not bind to virally produced interleukin-6 (IL-6) in a nonclinical study. Sylvant is an IL-6 antagonist biologic therapy administered as an intravenous (IV) infusion once every three weeks. Sylvant is the first approved treatment in the United States for MCD. 

 

MCD is a rare blood disorder with high morbidity in which lymphocytes, a type of white blood cell, are over-produced, leading to enlarged lymph nodes. MCD can also affect lymphoid tissue of internal organs, causing the liver, spleen or other organs to enlarge. Infections, multisystem organ failure and malignancies including malignant lymphoma are common causes of death in patients with MCD.

 

“There has been a serious need for treatment options for patients with MCD,” said Frits van Rhee, University of Arkansas for Medical Sciences, and MCD2001 study lead investigator. “MCD is a complex disease and up until this point, physicians have tried to reduce lymph node masses and put the disease in remission through a combination of treatments, but MCD often returns. [Wednesday’s] approval of Sylvant gives physicians a long-awaited treatment option for a group of patients who has been suffering with this chronic, serious and debilitating disease.”

 

MCD is a proliferative disease that acts very much like lymphoma (cancer of lymph nodes). It is so rare that it is difficult to track the number of cases, though a recent United States analysis estimates* the incidence of MCD at approximately 1,100 to 1,300 Americans. 

 

“[Wednesday’s] approval of a treatment for patients with multicentric Castleman’s disease marks a significant milestone for patients living with this rare disease and underscores the importance of ongoing research and development in areas where there are so few patients with such a high unmet medical need,” said Peter Saltonstall, president and CEO, National Organization of Rare Disorders (NORD), a federation of health organizations dedicated to helping people with rare diseases.

 

While the cause of MCD currently is unknown, overproduction of IL-6 is considered a key mechanism in MCD. Sylvant works by binding to human IL-6, a multifunctional cytokine produced by various cells such as T cells, B cells, monocytes, fibroblasts and endothelial cells. 

 

“Sylvant exemplifies Janssen’s approach to research and development, as well as our commitment to patients,” said Peter Lebowitz, global oncology head, Janssen. “Our expertise in hematologic malignancies was key to recognizing the potential for Sylvant in this rare disease. We’re extremely proud to be the first company with an approved medicine to treat MCD in the U.S.” 

 

Date: April 23, 2014

Source: Janssen Biotech