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Siltuximab (Sylvant) Gains FDA Approval ... But Not For Multiple Myeloma

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Published: Apr 28, 2014 11:41 am

Siltuximab, a drug that has been tested as a potential new treatment for multiple myeloma, was approved last week by the U.S. Food and Drug Administration (FDA).

Its approval, however, was as a new treatment for a form of Castleman's dis­ease, a rare disorder similar to lymphoma.

Siltuximab will be marketed in the United States by the Janssen Biotech division of Johnson & Johnson (NYSE:JNJ).  The drug's brand name will be Sylvant.

Johnson & Johnson also has submitted an application with the European Medi­cines Agency to market siltuximab in Europe as a treatment for Castleman's disease. A decision on the Euro­pe­an application, however, has not yet been announced.

Siltuximab has been investigated in several clinical trials as a potential treatment for myeloma.  Initial results for one trial were presented at the American Society of Hematology annual meeting in 2011.  The results showed that siltuximab was active against multiple myeloma, but patients treated with the drug also ex­peri­enced significant side effects (see related Beacon news article).   Updated results from that trial were pub­lished last year, and another study was published recently examining the impact of siltuximab on the heart function of myeloma patients treated with the drug.

Only one clinical trial of siltuximab in myeloma patients is still ongoing and recruiting patients.  The inter­na­tion­al multicenter trial is testing siltuximab as a potential treatment for high-risk smoldering myeloma.

It's not known whether the location of Janssen Biotech's headquarters – which is in Pennsylvania – influ­enced the company's decision to select Sylvant as the brand name for sil­tuximab.

For more information about siltuximab's FDA approval, see the related press releases from the FDA and Johnson & Johnson.

Photo by Jared Smith on Flickr - some rights reserved.
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2 Comments »

  • Igor said:

    What about TNF inhibitors? Can this class of drugs help treat myeloma?

  • Boris Simkovich said:

    Hello Igor - There have been a couple of laboratory studies suggesting that TNF inhibitors, such as Enbrel (etanercept) and Remicade (infliximab), could have an anti-myeloma effect. Tumor necrosis factor alpha (TNF-alpha) is thought to be protective of myeloma cells.

    However, I have not found any clinical trials that have been carried out to test any of the existing TNF inhibitors -- of which there are now five or six -- as potential myeloma therapies.