Articles tagged with: Siltuximab

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[ by | Apr 28, 2014 11:41 am | 2 Comments ]

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.

Press Releases»

[ by | Sep 3, 2013 10:11 am | Comments Off ]

Simultaneous Applications Submitted To FDA And EMA For Siltuximab For The Treatment Of Multi­centric Castleman Disease, A Rare Blood Disorder Raritan, NJ (Press Release) - Janssen Research & Development, LLC (“Janssen”) announced the si­mul­ta­ne­ous sub­missions of a Biologic License Application (BLA) to the United States Food and Drug Ad­min­is­tra­tion (U.S. FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for siltuximab for the treat­ment of patients with multicentric Castleman disease (MCD) who are HIV-negative and human herpes virus-8 (HHV-8)-negative.

MCD is a rare disorder in which lym­pho­cytes, a certain type of white blood cells, are over-produced and lead to enlargement of lymph nodes.[1,2] This can cause a variety …

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[ by and | May 24, 2013 4:23 pm | 8 Comments ]
The Future Of Treatment For Multiple Myeloma

In a recent review article pub­lished in the journal Clinical Cancer Re­search, two myeloma experts from the Dana-Farber Cancer In­sti­tute, Dr. Nikhil Munshi and Dr. Kenneth Anderson, review the latest strategies in the treat­ment of mul­ti­ple myeloma.

In their article, the experts discuss newer ther­a­pies that appear to be promising in clin­i­cal and pre­clin­i­cal stud­ies.

According to the physicians, com­bi­na­tion ther­a­pies that spe­cif­i­cally target a patient’s ge­netic form of the dis­ease will be re­quired for long-term dis­ease con­trol and ultimately a cure.

Some Historical Perspective

In their review article, Drs. Munshi and …

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[ by | Jun 4, 2012 5:28 pm | 10 Comments ]
ASCO 2012 Multiple Myeloma Update – Day Four: Immunotherapy For Myeloma

Today is the fourth day of the American Society of Clinical Oncology (ASCO) 2012 annual meeting, and the meeting con­tinued to be filled with in­ter­est­ing re­­sults from clin­i­cal trials in mul­ti­ple myeloma patients.

The day in­cluded a session of oral pre­sen­ta­tions in the late morn­ing that featured re­­sults from three clin­i­cal trials involving immuno­therapy agents.

The three com­pounds, elotuzumab, siltuximab, and daratumumab, belong to the class of drugs called mono­clonal anti­bodies. They work by identifying pro­teins on the surface of myeloma cells and signal for the im­mune sys­tem to …

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[ by | May 23, 2012 12:20 pm | 20 Comments ]
New Multiple Myeloma Treatments On The Horizon (ASCO 2012)

During the upcoming annual meeting of the American Society of Clinical Oncology (ASCO), results will be presented from clin­i­cal trials involving poten­tial new drugs under devel­op­ment for the treat­ment of multiple myeloma.

In particular, results for newer, lesser known agents that are in the early stages of clin­i­cal devel­op­ment will take center stage. These agents in­clude obatoclax, siltuximab, daratumumab, and SNS01-T.

According to the recently released ASCO abstracts, the agents showed varying degrees of activity in re­lapsed and refractory myeloma patients. So it will be particularly in­ter­est­ing to …

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[ by | May 16, 2012 1:53 pm | 7 Comments ]
Myeloma Research To Be Presented At The American Society of Clinical Oncology’s 48th Annual Meeting (ASCO 2012)

The 48th annual meeting of the American Society of Clinical Oncology (ASCO) will take place Friday, June 1, through Tuesday, June 5, in Chicago.

More than 25,000 clin­i­cal spe­cialists from all over the world are ex­pec­ted to attend the five-day meeting to discuss the cur­rent re­search in cancer treat­ment and care. The theme for this year’s meeting is “Collaborating to Conquer Cancer.”

The meeting will in­clude many pre­sen­ta­tions and seminars focused spe­cif­i­cally on mul­ti­ple myeloma. The ASCO website cur­rently lists nearly 50 myeloma-based pre­sen­ta­tions (included under “lymphoma and plasma cell disorders”).

The …

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[ by | Feb 3, 2012 1:46 pm | 6 Comments ]
Siltuximab May Be Effective In Certain Patients With Advanced Multiple Myeloma (ASH 2011)

The results of a recent Phase 2 clinical trial suggest that siltuximab in com­bi­na­tion with dexa­metha­sone may be effective for some multiple myeloma patients resistant to prior dexa­metha­sone-containing treatments. However, siltuximab in combination with high-dose dexa­metha­sone may be associated with a high rate of serious side effects.

Dr. Peter Voorhees from the Lineberger Comprehensive Cancer Center in Chapel Hill, North Carolina, presented these results at the 2011 American Society of Hematology (ASH) conference in San Diego last month.

Although Dr. Voorhees and his colleagues concluded that the combination of siltuximab and dexa­metha­sone …

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