Articles tagged with: Siltuximab
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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»
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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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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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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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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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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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 …