Articles tagged with: Subcutaneous Formulation
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Many new and promising research developments occurred in the field of multiple myeloma during 2011. Over the course of the year, The Myeloma Beacon published nearly 100 articles on important myeloma-related studies.
To identify the most important of these studies from 2011, The Myeloma Beacon surveyed leading physicians and researchers in the field. They were asked to name the three peer-reviewed journal articles published in 2011 and the three conference presentations from 2011 that have the most important findings or implications relating to multiple myeloma.
Their selections for the most important journal …
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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 (in the …
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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 …
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Yesterday was the first day of the American Society of Hematology (ASH) 2011 annual meeting, which is being held in San Diego.
Although the day featured no oral presentations of new myeloma-related research, it started with an interesting educational session focused on multiple myeloma.
There also were a number of poster presentations during the day summarizing important new research findings.
The educational session in the morning featured three presentations by leading myeloma specialists.
Induction Therapy And Maintenance Treatment
The first presentation was by Dr. Donna Reece of the Princess Margaret Hospital in …
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Multiple myeloma patients being treated with Velcade often experience peripheral neuropathy, which is nerve damage that causes pain, numbness, or tingling in the extremities. Recent studies have identified two ways of reducing neuropathy and other side effects associated with Velcade, while maintaining similar efficacy: administering Velcade intravenously once weekly instead of twice weekly or administering Velcade subcutaneously instead of intravenously.
Velcade (bortezomib) is currently approved to be used intravenously for the treatment of multiple myeloma in the United States and over 90 countries worldwide. Approximately 30 percent of multiple myeloma patients who …
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Millennium And Takeda Apply For FDA Approval Of Subcutaneous Velcade – Millennium and Takeda, the companies that market Velcade, have submitted an application to the Food and Drug Administration (FDA) for approval of Velcade (bortezomib) to be administered subcutaneously (injected into the fat just below the skin). Currently, Velcade is approved to be administered intravenously. Recent results have shown that subcutaneous Velcade is as effective as IV Velcade, but subcutaneous administration reduces the frequency and seriousness of side effects. In particular, the rate of peripheral neuropathy (pain and tingling in the extremities) dropped from 16 percent to 6 percent. Additionally, many patients may consider subcutaneous injections more convenient because they can be administered from home. For more information, see the Millennium press release or the Beacon’s coverage of the results comparing the efficacy and side effects of the two routes of administration.
Highlights From The 13th International Myeloma Workshop – The 13th International Myeloma Workshop will be held in Paris tomorrow through Friday. Staff from The Myeloma Beacon will be attending and reporting live from the meeting. The Beacon’s coverage will include brief “as it happens” summaries of presentations to be posted to the Beacon forums as well as daily update articles that summarize the day’s events and key presentations. Discussion threads have been created in the forums for each day of the meeting (Day 1, Day 2, Day 3, and Day 4). All Beacon readers are welcome to participate in the discussions. The Beacon’s coverage of the Workshop is made possible in part by financial support from the Tackle Cancer Foundation.
After the conclusion of the Workshop, the Multiple Myeloma Research Foundation (MMRF) will sponsor a teleconference for patients and caregivers in which myeloma specialists will present highlights from the meeting. Dr. Thierry Facon from the University of Lille in France as well as Dr. Paul Richardson from the Dana-Farber Cancer Institute will present the latest advances in myeloma treatment. Their presentation will be followed by a question and answer session. The call will take place on May 6 from noon till 1 p.m. Eastern time. For more information or to register, see the MMRF event website.
Multiple Myeloma Education Programs – Two educational programs for multiple myeloma patients will be held on May 14. Dr. Jeff Wolf will speak at the event held in San Jose, CA, and Dr. Ronjay Rakkit will speak at the event in Houston. The physicians will also answer patients’ questions. In addition, a multiple myeloma patient will speak at each program. Attendees can also connect with others at the event who have been affected by myeloma. Both events are sponsored by Millennium. For more information, see the Beacon event descriptions (San Jose, Houston). To register, call 1-866-508-6181.
NewsFlash »
Subcutaneous Velcade Injections Show Similar Efficacy But Fewer Side Effects Than IV Injections For Myeloma Patients – Results of a recent French study show that subcutaneous injections of Velcade (bortezomib) produce similar efficacy but fewer side effects for myeloma patients compared to IV injections. Dr. Philippe Moreau, the study’s lead investigator, first presented the results at the American Society of Hematology (ASH) annual meeting last December. The study authors compared the responses of 148 patients who received subcutaneous Velcade injections with 74 patients who received IV injections. They found that after receiving eight cycles of treatment, patients in both groups had similar response rates, median time to progression, and overall survival, but the frequency and severity of side effects were significantly lower in the patients who received subcutaneous injections. For a more detailed summary of the results, please see the Beacon’s coverage of Dr. Moreau’s presentation at ASH or the study in Lancet Oncology (abstract).
XTL Biopharmaceuticals Seeks FDA Orphan Drug Status Of Its Red Blood Cell Stimulator For Myeloma – The Israeli biopharmaceutical company XTL Biopharmaceuticals has requested that the U.S. Food and Drug Administration (FDA) grant orphan status to its red blood cell-stimulating agent erythropoietin for multiple myeloma. The compound is currently undergoing a Phase 2 clinical trial. Orphan status applies to drugs that treat rare diseases affecting under 200,000 Americans per year. It would grant incentives to XTL Biopharmaceuticals for developing erythropoietin, including shortened approval procedures, tax breaks on research and development costs, and financial assistance. For more information, please see the XTL Biopharmaceuticals press release.
Low Angiopoietin-1 To Angiopoietin-2 Ratio May Be Associated With Shorter Survival In Myeloma Patients – Results of a recent study involving 174 newly diagnosed myeloma patients show that a low angiopoietin-1/angiopoietin-2 ratio may be associated with a poorer prognosis for myeloma patients, including shorter survival and a higher frequency of kidney problems and extensive bone disease. Angiopoietin-1 and angiopoietin-2 belong to a category of proteins involved in the formation and development of new blood vessels. The study authors found that patients with an angiopoietin-1/angiopoietin-2 ratio equal to or below the median ratio had a median survival of 26.3 months compared to 53 months for other patients. The study authors also observed a decreased angiopoietin-1/angiopoietin-2 ratio mostly in patients who previously received therapy with novel agents. For more information, please see the article in the International Journal of Cancer (abstract).
MMRF Founder And CEO Kathy Giusti Named In List Of Top 100 Most Influential People In The World – Kathy Giusti, founder and CEO of the Multiple Myeloma Research Foundation (MMRF), was named one of the 100 most influential people in the world in the May 2 issue of TIME Magazine. Giusti was diagnosed with multiple myeloma in 1996 at the age of 37. After receiving high-dose chemotherapy as well as a stem cell transplant in 2006, Giusti has been in remission to the present day. Giusti founded the MMRF in 1998. Since then, the organization has raised over $165 million for myeloma research. In 2004, she founded the Multiple Myeloma Research Consortium to focus on conducting Phase 1 and Phase 2 clinical trials of myeloma drugs. In addition, Giusti has served on the Cancer Leadership Council and the National Cancer Policy Board of the Institute of Medicine, and currently serves on the National Cancer Advisory Board. For more information, please see the MMRF press release.
