FDA approves Sylvant for treatment of Castleman's Disease - Janssen Biotech

The FDA on 23 April 2014 approved Sylvant (siltuximab) from Janssen Biotech to treat patients with multicentric Castleman�s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes). MCD causes an abnormal overgrowth of immune cells in lymph nodes and related tissues in the body. The disease usually affects adults who often suffer from fever, night sweats, weight loss and weakness or fatigue because their body�s immune system is weakened and cannot fight infections. Sylvant is an injection that works by blocking a protein that stimulates abnormal growth of immune cells. It is intended for patients with MCD who do not have HIV or human herpes virus 8 (HHV-8).

Sylvant�s safety and effectiveness were evaluated in a clinical trial of 79 participants with MCD who were HIV and HHV-8 negative. Participants were randomly assigned to receive a combination of Sylvant and best supportive care, or placebo and best supportive care. Results showed 34 percent of participants treated with Sylvant and best supportive care experienced tumour response, while no participant treated with placebo and best supportive care did.

The Committee for Medical Products for Human Use (CHMP) of The European Medicines Agency (EMA) in March 2014, adopted a positive opinion recommending the granting of a marketing authorisation for CNTO 328 (siltuximab), from Janssen-Cilag, for the treatment of adult patients with multicentric Castleman's Disease (MCD) who are HIV-negative and human herpes virus-8 (HHV-8)-negative.