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| FDA Oncology Chief Richard Pazdur |
J&J has won FDA approval for a new drug that fights a rare blood disorder known as multicentric Castleman's disease.
Similar to lymphoma, MCD is characterized by an abnormal growth of immune cells in lymph nodes. In a study involving 79 patients with the disease, investigators found that siltuximab (CNTO 328) triggered a tumor response in about a third of the drug arm--compared to none taking a placebo. The drug will now be marketed as Sylvant to a patient population of about 1,200.
"Sylvant is the first FDA-approved drug to treat patients with MCD," said Richard Pazdur, the cancer drug czar at the FDA.
J&J ($JNJ) isn't done with siltuximab, an anti-IL-6 antibody that's delivered in an IV formulation. According to clinicaltrials.gov it's also being studied for multiple myeloma. Last summer J&J reported that it had stopped a study for metastatic prostate cancer after the monitoring committee called it off for lack of efficacy.
"There has been a serious need for treatment options for patients with MCD," said Frits van Rhee, the lead investigator. "MCD is a complex disease and up until this point, physicians have tried to reduce lymph node masses and put the disease in remission through a combination of treatments, but MCD often returns. Today's approval of SYLVANT gives physicians a long-awaited treatment option for a group of patients who has been suffering with this chronic, serious and debilitating disease."
- here's the FDA release
- get the release from J&J