SYLVANT 100 and 400 mg Vials

The US Food and Drug Administration has approved Janssen Biotech’s Sylvant (siltuximab) to treat patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.

The company said that the drug was not studied in patients with MCD who are HIV positive or HHV-8 positive because it did not bind to virally produced interleukin-6 (IL-6) in a non-clinical trial.

An IL-6 antagonist biologic therapy administered as an intravenous (IV) infusion once every three weeks, Sylvant is claimed to be the first approved treatment in the US for MCD, a rare blood disorder with high morbidity that involves lymphocytes being over-produced, which leads to enlarged lymph nodes.

MCD can also affect lymphoid tissue of internal organs, causing the liver, spleen or other organs to enlarge. Other common causes of death in patients with this disease include infections, multisystem organ failure and malignancies including malignant lymphoma.

University of Arkansas for Medical Sciences professor of medicine and MCD2001 study lead investigator Dr Frits van Rhee said there has been a serious need for treatment options for patients with MCD.

"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 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," Dr van Rhee said.

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"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."

Efficacy and safety of Sylvant were evaluated in a multi-national, randomised, double-blind, placebo-controlled trial carried out in 79 patients with MCD.

In this trial, 53 patients were randomised to the Sylvant arm at a dose of 11mg/kg and 26 patients were randomised to the placebo arm.

Janssen head of global oncology Peter Lebowitz said: "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 US."

Image: Sylvant 100mg and 400mg vials. Photo: courtesy of PRNewsFoto/Janssen Biotech.