Independent, up-to-date news and information for multiple myeloma patients and their families.
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.
Combined data from two recent Phase 1 clinical trials suggest that twice-weekly marizomib, with or without low-dose dexamethasone, may be effective for patients with relapsed or refractory multiple myeloma.
Dr. David Vesole from the John Theurer Cancer Center in Hackensack, New Jersey, who was not involved in the study, described marizomib as having “modest activity in relapsed/refractory myeloma.”
Dr. Paul Richardson from the Dana-Farber Cancer Institute in Boston presented the results at the American Society of Hematology (ASH) annual meeting in San Diego last month.
Marizomib (NPI-0052), which is being…
Throughout 2011, The Myeloma Beacon published many articles that serve as helpful resources for multiple myeloma patients and others interested in myeloma.
These articles included interviews with, columns written by, and summaries of treatment guidelines from leading myeloma experts. They also included articles providing helpful information about rare types of myeloma and exciting new treatment options that are being studied in clinical trials.
All these articles were published in addition to the Beacon’s coverage of the latest myeloma-related news and research results, and in addition to the Beacon’s columns written…
The results of a small Phase 1 clinical trial demonstrate that BT-062, a new drug specifically targeting multiple myeloma cells, shows activity and is tolerable in heavily pretreated multiple myeloma patients.
Dr. Sundar Jagannath of the Mount Sinai Medical Center in New York City presented the results at the 2011 American Society of Hematology (ASH) conference in San Diego last month.
Based on the favorable safety and activity of BT-062, a Phase 1/2 clinical trial has been initiated and is currently recruiting patients. It will use a more…
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