FDA Approves Treatment for Castleman's Disease

The FDA has approved the first drug for the treatment of multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma.

In MCD, patients have an abnormal overgrowth of immune cells in lymph nodes and related body tissues. Symptoms of MCD include fever, night sweats, weight loss and weakness or fatigue, caused by a weakened immune system's inability to fight infections.

The approved drug is Sylvant (siltuximab), 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 is the first FDA-approved drug to treat patients with MCD,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. "Today’s approval demonstrates the FDA’s commitment to approving drugs for rare diseases."

Sylvant was reviewed under the FDA's priority review program, which provides an expedited review for drugs that demonstrate the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition. Sylvant was also granted orphan product designation because it is intended to treat a rare disease or condition.

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 tumor response, while no participant treated with placebo and best supportive care did.

Common side effects include itchy skin (pruritis), weight gain, rash, increased levels of uric acid in the blood and upper respiratory tract infection.

Source: FDA

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