Health & Medicine
FDA Okays New Drug Sylvant to Treat Rare Castleman’s Disease
Benita Matilda
First Posted: Apr 24, 2014 05:57 AM EDT
Janseen Biotech's drug Sylvant has won the approval of the U.S. Food and Drug Administration regulators to treat rare Castleman's disease.
The newly approved 'Sylvant' is an injection that will play a key role by blocking a protein that is known to stimulate abnormal growth of the immune cells. This drug is solely meant for patients with multicentric Castleman's disease (MCD) and who are not diagnosed with HIV or human herpes virus 8 (HHV-8).
The rare disorder MCD is much like lymphoma i.e. cancer of the lymph nodes. MCD causes an abnormal growth of immune cells in the lymph nodes and other related tissues in the human body. This rare disorder is not considered as cancer but it is linked with an elevated risk of lymphoma.
The symptoms of this disease are loss of appetite, unintended weight loss, nausea and vomiting, weakness, fatigue, enlarged liver or spleen, damaged nerves in hands and feet leading to numbness or weakness, night sweats, fever and enlarged peripheral lymph nodes.
"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."
The safety and effectiveness of the drug was evaluated in a clinical trial that included over 79 subjects who were diagnosed with MCD and were HIV and HHV-8 negative. To check the safety, the study participants were randomly given a combination of Sylvant along with supportive care or they were given a placebo along with supportive care.
The researchers saw that nearly 34 percent of the participants who were treated with Sylvant and given supportive care experienced tumor response while no response was seen in those treated with placebo and supportive care.
Some of the common side effects reported by the participants were itchy skin, weight gain, rash, increased levels of uric acid in blood and upper respiratory tract infection.
This new drug 'Sylvant' was reviewed under FDA's priority program. Since it is meant to treat a rare disease or condition, the regulators granted Sylvant an orphan product designation.
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First Posted: Apr 24, 2014 05:57 AM EDT
Janseen Biotech's drug Sylvant has won the approval of the U.S. Food and Drug Administration regulators to treat rare Castleman's disease.
The newly approved 'Sylvant' is an injection that will play a key role by blocking a protein that is known to stimulate abnormal growth of the immune cells. This drug is solely meant for patients with multicentric Castleman's disease (MCD) and who are not diagnosed with HIV or human herpes virus 8 (HHV-8).
The rare disorder MCD is much like lymphoma i.e. cancer of the lymph nodes. MCD causes an abnormal growth of immune cells in the lymph nodes and other related tissues in the human body. This rare disorder is not considered as cancer but it is linked with an elevated risk of lymphoma.
The symptoms of this disease are loss of appetite, unintended weight loss, nausea and vomiting, weakness, fatigue, enlarged liver or spleen, damaged nerves in hands and feet leading to numbness or weakness, night sweats, fever and enlarged peripheral lymph nodes.
"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."
The safety and effectiveness of the drug was evaluated in a clinical trial that included over 79 subjects who were diagnosed with MCD and were HIV and HHV-8 negative. To check the safety, the study participants were randomly given a combination of Sylvant along with supportive care or they were given a placebo along with supportive care.
The researchers saw that nearly 34 percent of the participants who were treated with Sylvant and given supportive care experienced tumor response while no response was seen in those treated with placebo and supportive care.
Some of the common side effects reported by the participants were itchy skin, weight gain, rash, increased levels of uric acid in blood and upper respiratory tract infection.
This new drug 'Sylvant' was reviewed under FDA's priority program. Since it is meant to treat a rare disease or condition, the regulators granted Sylvant an orphan product designation.
See Now: NASA's Juno Spacecraft's Rendezvous With Jupiter's Mammoth Cyclone