Independent, up-to-date news and information for multiple myeloma patients and their families.
Here are all the latest news articles written by The Beacon’s staff.
For news articles about treatments commonly given to myeloma patients, click on these links:
bisphosphonates, Revlimid, thalidomide, Velcade, and Zometa.
For news articles about potential new myeloma treatments, click on these links:
carfilzomib, elotuzumab, panobinostat, perifosine, pomalidomide, and Zolinza.
For news articles about specific myeloma-related topics, click on these links:
bone disease, kidney failure, MGUS, maintenance therapy, secondary cancer, smoldering multiple myeloma, and stem cell transplants.
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…
A group of myeloma experts from the International Myeloma Working Group recently published a consensus statement on maintenance therapies for myeloma patients.
In their statement, the experts reviewed the main findings from previous clinical trials that investigated the impact of maintenance therapies containing the novel agents thalidomide (Thalomid), Revlimid (lenalidomide), and Velcade (bortezomib).
Maintenance therapy is a prolonged, and often low-dose, form of treatment given to myeloma patients after their initial therapy. The goal of maintenance therapy is to prevent disease progression for as long as possible…
Celgene announced this morning that it plans to submit an application for the approval of pomalidomide for relapsed and refractory multiple myeloma to the U.S. Food and Drug Administration (FDA) during the first quarter of 2012.
In addition, the company said that it plans to submit a similar application to the European Medicines Agency (EMA) during the first half of this year.
The updated submission timeline means that pomalidomide could be approved for use in the United States and in Europe by the end of this year.
Celgene’s announcement was made…
Earlier this week, the U.S. Food and Drug Administration approved subcutaneous administration of Velcade (see related Beacon news). Previously, intravenous administration was the only approved method.
More details are provided in this article to answer multiple myeloma patients’ questions about the FDA decision.
What exactly did the FDA approve?
The FDA approved a supplemental new drug application for Velcade (bortezomib), which is an application to make changes to an already approved product. Specifically, the FDA approved updated prescribing information that now says Velcade can be administered by intravenous…
Millennium: The Takeda Oncology Company announced today that the U.S Food and Drug Administration has approved subcutaneous administration of Velcade for the treatment of multiple myeloma and relapsed mantle cell lymphoma.
Velcade (bortezomib), which is marketed by Millennium and its parent company Takeda Pharmaceutical Company Limited (TSE:4502), is currently approved to be administered intravenously (infused into a vein).
The FDA decision to approve the subcutaneous administration of Velcade (injection into fat just below the skin, often abbreviated as subcu or subQ) was based on results of a Phase 3 study comparing subcutaneous and intravenous administration of Velcade for myeloma patients.
The results showed that subcutaneous Velcade is as effective as intravenous Velcade, but subcutaneous administration reduces the frequency and seriousness of side effects. In particular, subcutaneous Velcade causes less peripheral neuropathy, pain and tingling in the extremities and a common side effect of Velcade (see related Beacon news).
In addition to being safer, subcutaneous Velcade may be more convenient for many patients. Subcutaneous administration is faster and does not require an accessible vein. Currently, subcutaneous Velcade is being administered in hospitals or clinics by health care professionals, but eventually patients may be able to administer it at home.
Although subcutaneous administration of Velcade was not officially approved by any regulatory agencies until today, some physicians in the United States and several other countries have been administering Velcade subcutaneously since the release of the clinical trial results showing better tolerability (see related Beacon news).
The prescribing information for Velcade will be updated to say that Velcade can be used via intravenous or subcutaneous administration, but not intrathecal administration (injection into the spinal canal). Inadvertent injection into the spinal canal has resulted in death.
For more information about the FDA approval, see the Millennium press release.
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