Sylvant Approved For Treatment Of Castleman's Disease

Sylvant (siltuximab), Janssen Biotech’s Castleman’s disease drug, has been approved by the FDA for use in adults that do not have HIV or the human  herpes virus 8. To date, it is the first drug to have been approved for the treatment of multicentric Castleman’s disease, or MCD. The drug underwent an expedited review process, which is reserved for drugs that show the potential to help patients who are suffering from diseases with few current options for treatment. In both the US and in the EU, the drug has been granted orphan drug designation. It was also recently recommended for approval in the EU.

MCD is a rare blood disorder that is similar to lymphoma. It is believed to afflict between 1,100 and 1,300 people in the United States. Overgrowth of lymphocytes can lead to MCD, which enlarges lymph nodes. The liver, spleen, and other organs with lymphoid tissue can be affected. Patients with MCD are prone to infection and even multisystem organ failure. The cause of MCD is currently unknown, though researchers associate it with the overproduction of interleukin (IL)-6.

Janssen’s clinical trial that got the drug approval was named MCD2001. The trial contained 79 patients with MCD who did not have either HIV or human herpes virus 8. The study showed that 34 percent of patients given Sylvant saw reduction in tumor size, and those reductions remained for a minimum of 18 weeks while on the treatment. None of the patients receiving the placebo experienced a reduction in tumor size or a lessening of disease symptoms.

Dr. Frits van Rhee, who headed the drug’s clinical trial, says, “There has been a serious need for treatment options for patients with MCD,” said van Rhee. “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. Siltuximab gives physicians a long-awaited treatment option for a group of patients that have been suffering with this chronic, serious, and debilitating disease.”