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FDA approves Janssen drug for rare Castleman’s disease

Sylvant approved to treat lymphoma-like condition
FDA headquarters White Oak

The US FDA has approved a new drug to treat a rare cancer-like condition known as multicentric Castleman's disease.

Sylvant (siltuximab), marketed by Johnson & Johnson subsidiary Janssen Biotech, is the first drug backed by the FDA to treat multicentric Castleman's disease, which the agency describes as a rare disorder similar to the blood cancer lymphoma.

Castleman's disease usually occurs in adults with a weakened immune system and is characterised by an abnormal overgrowth of immune cells in lymph nodes and related tissues in the body.

The multicentric form means more than a single group of lymph nodes are affected and patients experience a severely weakened immune system, making it harder to fight infection as well as an increased risk of developing lymphoma.

Due to the severity of the disease and lack of current treatment options Sylvant was assessed by the FDA under its priority review programme. It is also designated an orphan drug due to the rarity of multicentric Castleman's disease

Sylvant's approval does not cover every patient with the disease, however, excluding those who have HIV or human herpes virus 8 (HHV-8), both of which lead to a weakened immune system.

Nevertheless, the approval will be welcomed by Janssen, which demonstrated the safety and effectiveness of Sylvant in its approved indication during a clinical trial of 79 patients who did not have HIV or HHV-8.

The trial showed that 34 per cent of participants treated with Sylvant and best supportive care experienced tumour response, while no participant treated with placebo and best supportive care did.

Sylvant is also under review in the EU where Janssen submitted a drug filing in September last year.

Article by
Thomas Meek

24th April 2014

From: Sales



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