The FDA approved Janssen Biotech's new Sylvant injection as a new treatment for multicentric Castleman's disease (MCD).
The injection blocks a protein that stimulates the abnormal growth of immune cells. The new treatment can be used by patients with MCD who don't 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 in a press statement. "Today's approval demonstrates the FDA's commitment to approving drugs for rare diseases."
The new drug was reviewed under the FDA's priority review program, which provides an accelerated 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 an orphan product designation because it treats a rare disease.
The drug was tested on 79 participants with MCD who were HIV and HHV-8 negative as part of a clinical trial. All participants either received Sylvant combined with supportive care or were give a placebo with similar supportive care. Researchers noted that 34 percent of the participants treated with Sylvant experienced positive tumor response.
The side effects of the drug included itchy skin (pruritis), weight gain, rash, increased levels of uric acid in the blood and upper respiratory tract infection.
MCD is a condition that results in abnormal immune cell growth in lymph nodes and related tissues in the body. Individuals who suffer from fever, night sweats, weight loss and weakness or fatigue because of weak immune systems are more susceptible to this disease. This condition is similar to lymphoma (cancer of the lymph nodes). Treating the disease is quite difficult as it is rare and doesn't have any specific signs or symptoms and can sometimes go into remission. However, there are a few non-surgical treatments for MCD currently.
