Articles tagged with: Europe
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An advisory committee of the European Medicines Agency has issued a positive opinion regarding European approval of Farydak (panobinostat) for the treatment of certain patients with multiple myeloma.
Specifically, the Committee for Medicinal Products for Human Use (CHMP) recommended that Farydak be approved for use in combination with Velcade (bortezomib) and dexamethasone (Decadron) for the treatment of relapsed and/or refractory multiple myeloma patients who have received at least two prior treatment regimens.
The two prior regimens must include Velcade and at least one treatment from the immunomodulatory class of drugs, …
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Velcade Receives Additional Approvals In Europe – The approved uses of Velcade (bortezomib) for multiple myeloma patients were recently expanded in the European Union. These additional approved uses include treatment of newly diagnosed transplant-eligible myeloma patients with Velcade plus dexamethasone (Decadron) or Velcade plus thalidomide (Thalomid) and dexamethasone, as well as retreatment of relapsed myeloma patients with Velcade for those who responded to prior Velcade therapy. Previously, Velcade was approved in combination with melphalan (Alkeran) and prednisone for the treatment of newly diagnosed myeloma patients who are ineligible for stem cell transplantation, or as a single agent for the treatment of relapsed myeloma patients with one prior therapy who have had a transplant or are ineligible for a transplant. For more information, please see the August 8 and June 28 Johnson & Johnson press releases about the new approvals for newly diagnosed and relapsed myeloma patients.
Pilot Clinical Trial To Test Whether Anti-Depressant Desipramine Assists With Stem Cell Mobilization – Researchers from the Albert Einstein College of Medicine in New York City have launched a clinical trial that will determine how well the antidepressant desipramine (Norpramin, Pertofrane) in combination with Neupogen (filgrastim), which is a type of granulocyte colony-stimulating factor (G-CSF), works to mobilize stem cells in multiple myeloma patients undergoing stem cell transplantation. A previous study in mice showed that desipramine plus G-CSF mobilized more stem cells than G-CSF alone. For more information about the study or how to enroll, see the clinical trial description.
Clinical Trial To Study Modified Version Of Melphalan Plus Dexamethasone For Relapsed / Refractory Myeloma – A new Phase 1/2 clinical trial is testing the efficacy and safety of a modified version of melphalan in combination with dexamethasone for relapsed and refractory myeloma patients. The modified version of melphalan, known as melphalan-flufenamide or melflufen, is being developed by the Swedish pharmaceutical company Oncopeptides and consists of melphalan bound to flufenamide. The drug only becomes active once it enters a cell and melphalan is released from flufenamide. Cancer cells more efficiently activate the drug, increasing the concentration of melphalan in cancer cells compared to healthy cells. The study is sponsored by Oncopeptides and is being conducted in the United States and Europe. For more information about the study or how to enroll, see the clinical trial description and related Oncopeptides press release.
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An advisory committee of the European Medicines Agency has issued a positive opinion regarding European approval of pomalidomide for the treatment of certain patients with multiple myeloma.
Specifically, the Committee for Medicinal Products for Human Use (CHMP) recommended that pomalidomide be approved for use in combination with dexamethasone (Decadron) for the treatment of relapsed and refractory multiple myeloma patients who have received at least two prior therapies, including both Revlimid (lenalidomide) and Velcade (bortezomib), and have demonstrated disease progression while on their last therapy.
The …
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Leading myeloma specialists from across Europe recently published an article in the journal The Oncologist that summarized the current treatment options and availability of therapeutic agents for multiple myeloma patients in Europe. This article, Part 4 in the series, summarizes the European authors’ recommendations for the management of side effects.
The European authors provided recommendations for managing side effects related to novel agent use in myeloma patients. The recommendations are similar to how the side effects are managed in the United States.
Blood Clots
Blood clots are one of the …
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Leading myeloma specialists from across Europe recently published an article in the journal The Oncologist that summarized the current treatment options and availability of therapeutic agents for multiple myeloma patients in Europe. This article, Part 3 in a series, summarizes the European physicians’ treatment recommendations for patients with relapsed myeloma. Part 1 compares availability of myeloma treatments in Europe and the U.S., and part 2 summarizes physician’s treatment recommendations for newly diagnosed patients. Part 4 will cover the management of side effects.
Although recent clinical trials have demonstrated that novel …
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Leading myeloma specialists from across Europe recently published an article in the journal The Oncologist that summarized the current treatment options and availability of therapeutic agents for multiple myeloma patients in Europe. This article, Part 2 in a series, summarizes the European physician’s treatment recommendations for newly diagnosed patients. Part 1 compares availability of myeloma treatments in Europe and the U.S., and subsequent articles will summarize treatment recommendations for relapsed patients and management of side effects.
First-Line Treatment Practices
Due to more restrictive approved uses in Europe, there are also significant …
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Leading myeloma specialists from across Europe recently published an article in the journal The Oncologist that summarized the current treatment options and availability of therapeutic agents for multiple myeloma patients in Europe. This article, Part 1 in a series, compares availability of the treatments in Europe and the United States. Subsequent articles will summarize the European physicians’ treatment recommendations for newly diagnosed patients, relapsed patients, and management of side effects.
Prior to the introduction of novel therapeutic agents within the last two decades, the treatment options for multiple myeloma patients were rather …
