FDA Approves Janssen's Sylvant For Multicentric Castleman's Disease

Janssen Biotech, Inc. announced in a press release that the Food and Drug Administration (FDA) has approved Sylvant (siltuximab). The monoclonal antibody is indicated for multicentric Castleman’s disease (MCD) in patients who are human immunodeficiency virus (HIV) negative and human herpes virus-8 (HHV-8) negative. The FDA previously granted Sylvant orphan drug status and priority review of the Biologics License Application (BLA).

Peter F. Lebowitz, Global Oncology Head at Janssen said, “Sylvant exemplifies Janssen’s approach to research and development, as well as our commitment to patients. 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.”

Sylvant

Sylvant (siltuximab) is a chimeric monoclonal antibody that binds to interleukin-6 (IL-6). Overproduction of IL-6 is implicated in MCD. Patients take the biologic therapy by intravenous (IV) infusion once every three weeks. The FDA approved the therapy based on clinical trials, including the MCD2001 Pivotal Study, a global, multi-center, placebo controlled trial of 79 patients with MCD. 53 patients took Sylvant and 26 patients took a placebo. One third of the Sylvant patients experienced a reduction in disease symptoms and tumor size compared to the placebo patients who had no improvement. The effects of Sylvant lasted for a minimum of 18 weeks. Adverse events included itching, rash, increased weight, and upper respiratory infection.

Multicentric Castleman’s Disease

Multicentric Castleman’s disease (MCD) is a type of Castleman's disease (CD) with a high morbidity rate. Unicentric Castleman’s disease is local to one or a group of lymph nodes and is often treated by surgically removing it, while multicentric CD has spread to different anatomical areas and is much harder to treat. A rare disease, it is not a cancer but it acts much like a cancer of the lymph nodes. Known as a lymphoproliferative disorder, cells grow unchecked in the lymph system. MCD is treated with surgery, radiation, and chemotherapy. Other treatments offer symptom relief as patients often contract infections, fevers, and nerve damage. MCD weakens the immune system so infections are a real threat and may be fatal.

Access to Sylvant

Janssen Biotech offers support to health care professionals and patients in obtaining the treatment. The SylvantOne Support program helps identify insurance and cost support options. The program can provide information on the SylvantOne Patient Rebate Program and information for the uninsured.