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FDA approves Sylvant for multicentric Castleman’s disease
The FDA today approved siltuximab for treatment of a rare lymphoproliferative disorder that often serves as a precursor to lymphoma.
Siltuximab (Sylvant, Janssen Biotech) is the first FDA-approved drug for multicentric Castleman’s disease (MCD), a form of Castleman’s disease that affects more than a single group of lymph nodes.
MCD — which also can affect other organs that contain lymphoid tissue — causes an overgrowth of immune cells in lymph nodes and related tissues, weakening the immune system and limiting the body’s ability to fight infection.
The disease often acts like lymphoma, and an estimated 20% of those with MCD eventually develop lymphoma, according to NIH.
Siltuximab injection blocks the protein that stimulates the abnormal growth of immune cells.
The agent is indicated for patients with MCD who do not have HIV or human herpes virus 8 (HHV-8), according to an FDA press release.
The FDA approved siltuximab under its priority review program, which allows for expedited review of agents that demonstrate the potential to offer a major advance in treatment or provide a treatment where no adequate therapy exists. There has been no standard therapy for MCD, with treatment options ranging from antiviral drugs and chemotherapy to corticosteroids and immunomodulators. The FDA also granted orphan drug status to siltuximab because it is intended to treat a rare condition.
The FDA based its approval in part on results of a clinical trial that included 79 individuals with MCD who were HIV and HHV-8 negative. Researchers randomly assigned patients to siltuximab or placebo. All patients also received best supportive care.
Results indicated 34% of patients assigned siltuximab demonstrated tumor response, whereas no patient in the placebo arm demonstrated tumor response.
Adverse events frequently reported by patients assigned to siltuximab include pruritis, weight gain, rash, increased levels of uric acid in the blood and upper respiratory tract infection, according to the FDA.