FDA approves sylvant for multicentric castleman's disease

FDA approves sylvant for multicentric castleman's disease

(HealthDay)—The U.S. Food and Drug Administration has approved Sylvant (siltuximab) to treat patients with multicentric Castleman's disease (MCD), according to a news release issued by the agency today.

The drug is given as an injection and works by blocking a protein that stimulates of immune cells. It is intended for patients with MCD who are not infected with HIV or 8 (HHV-8).

Sylvant was evaluated in 79 participants with MCD who were HIV and HHV-8 negative. The results showed that tumor response was experienced by participants receiving a combination of Sylvant and best supportive care, but not by participants receiving placebo and best supportive care. Itchy skin, weight gain, rash, increased levels of in the blood, and upper were found to be common side effects.

Sylvant was reviewed by the FDA under its priority review program, and the drug has been given orphan product designation as it is intended to treat a rare disease or condition.

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

Sylvant is marketed by Janssen Biotech Inc., based in Horsham, Pa.

More information: More Information

Related Stories

Cyramza approved for stomach cancer

date Apr 22, 2014

(HealthDay)—Cyramza (ramucirumab) has been approved by the U.S. Food and Drug Administration to treat cancer of the stomach or of the area where the esophagus joins the stomach (the gastroesophageal junction).

Simponi approved for ulcerative colitis

date May 15, 2013

(HealthDay)—Simponi (golimumab) injection has been approved by the U.S. Food and Drug Administration to treat adults with moderate-to-severe ulcerative colitis.

Imbruvica approved for mantle cell lymphoma

date Nov 13, 2013

(HealthDay)—Imbruvica (ibrutinib) has been approved by the U.S. Food and Drug Administration to treat mantle cell lymphoma (MCL), a rare but aggressive form of blood cancer.

FDA OKs expanded use of prostate cancer drug

date Dec 10, 2012

(HealthDay)—The approved use of the drug Zytiga has been expanded to include treatment of men with late-stage, hormone therapy-resistant prostate cancer before they undergo chemotherapy, the U.S. Food ...

Recommended for you

Teva to lift bid for Mylan: report

date Jul 06, 2015

Israeli pharmaceutical giant Teva plans to increase its bid for rival Mylan and could announce the move as soon as this week, according to a US media report Monday.

Vaccine for West Nile Virus enters human clinical trials

date Jul 06, 2015

A clinical trial of a new investigational vaccine designed to protect against West Nile Virus infection will be sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes ...

FDA clears drug for leading form of cystic fibrosis

date Jul 02, 2015

Federal health officials have approved a new combination drug for the most common form of cystic fibrosis, the debilitating inherited disease that causes internal mucus buildup, lung infections and early death. But it will ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.