Articles tagged with: Melphalan
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This year’s American Society of Clinical Oncology (ASCO) annual meeting began yesterday morning in Chicago and will run through Tuesday.
Myeloma-related presentations were made during two sessions yesterday.
One session was designed to better educate physicians about personalized therapy for elderly patients with lymphoid malignancies. During that session, Dr. Tanya Marya Wildes from the Washington University School of Medicine in St. Louis talked about how to navigate treatment options for older multiple myeloma patients.
The key myeloma-related research presented yesterday was made public during a poster session in the afternoon about studies …
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Celgene Submits Revlimid For Approval As First-Line Therapy – The pharmaceutical company Celgene has announced that it has filed applications with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) seeking official approval of Revlimid (lenalidomide) as a treatment for newly diagnosed multiple myeloma. The application with the FDA was filed in April, while the EMA application was filed in February. Analysts expect the agencies to reach decisions on the applications by the middle of next year. Revlimid currently has regulatory approval in the U.S. and Europe for use in relapsed and refractory myeloma. However, Revlimid – alone or in combination with other anti-myeloma agents – is often used for the treatment of newly diagnosed patients in the United States, where such “off-label” prescribing is legally permitted. Because off-label prescribing is less common outside the U.S., a positive EMA decision in regard to the Revlimid application could significantly expand the drug's use in Europe. For more information, please see the Celgene press release regarding its 2014 first quarter earnings.
U.K. Agency Approves Velcade For Newly Diagnosed Myeloma – The National Institute for Health and Clinical Excellence (NICE), the agency that sets treatment guidelines for the U.K.'s National Health Service in England and Wales, earlier this week approved the use of Velcade (bortezomib) in newly diagnosed multiple myeloma patients eligible for stem cell transplantation. The decision specifies that Velcade is to be given in combination with dexamethasone (Decadron) or with dexamethasone and thalidomide (Thalomid). This week's NICE decision supplements a 2011 decision regarding the use of Velcade in newly diagnosed patients ineligible for transplantation. For those patients, however, NICE has approved the use of Velcade only if a patient cannot tolerate treatment with thalidomide (see related Beacon news). For more information, see the NICE press release.
New Formulation Of IV Melphalan Meets Primary Endpoint In Key Phase 2 Trial – The pharmaceutical company Spectrum Pharmaceuticals announced earlier this week that its Phase 2 pivotal trial of a new formulation of intravenous melphalan (Alkeran) met its primary endpoint. Given the results of the trial, the company is expected to file an application with the FDA during the third quarter of this year requesting permission to market the drug in the United States. The new formulation of melphalan, which Spectrum calls "Captisol-enabled melphalan", does not include propylene glycol, a chemical that has been reported to have heart- and kidney-related side effects. The Captisol technology also improves the stability of Spectrum's melphalan formulation. Together, the improved stability and lack of propylene glycol may allow Spectrum's formulation to be administered at doses higher than can be safely achieved with currently available melphalan formulations. Captisol technology also is used in the formulation of Kyprolis (carfilzomib). The primary endpoint in the pivotal Phase 2 trial of propylene gylcol-free melphalan was overall safety. The drug was tested at a dose of 200 mg/m2 in myeloma patients undergoing autologous (own) stem cell transplantation. Currently available formulations of melphalan also are typically dosed at 200 mg/m2 dose when they are used during the stem cell transplant process. For more information, please see the Spectrum Pharmaceuticals press release.
Press Releases»
- CE Melphalan is being developed as a novel version of the well-established conditioning treatment in autologous transplant for patients with multiple myeloma. CE Melphalan does not contain propylene glycol, an ingredient in currently available products which has been associated with renal and cardiac side effects.
- In its pivotal trial, CE Melphalan met its primary endpoint. The improved stability profile of CE Melphalan could lead to rapid adoption in the transplant conditioning market.
- The company expects to file an NDA in the 3rd quarter and plans to
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The findings of a recent retrospective study may alleviate some of the concerns patients and physicians have had about Revlimid and the risk of secondary cancers.
The study found that the risk of developing a secondary cancer as a result of treatment with Revlimid occurred mainly when a patient had been treated with oral melphalan at the same time as Revlimid.
Revlimid (lenalidomide) did not appear to be associated with an increased risk of secondary cancers when administered together with dexamethasone or cyclophosphamide.
In addition, although treatment with Revlimid before …
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One of the key presentations during the recent American Society of Hematology (ASH) annual meeting in New Orleans was one that summarized initial results of a large international Phase 3 clinical trial known as the "FIRST", or MM-020, trial.
The trial results show that continuous administration of Revlimid and dexamethasone improves response rates as well as progression-free and overall survival in newly diagnosed multiple myeloma patients who are older or not eligible for stem cell transplantation.
Specifically, the researchers found that the overall response rate was highest (75 percent) among patients who received …
Press Releases»
- Expected NDA filing mid-2014.
- Granted Orphan designation by the FDA as a conditioning treatment for use in autologous transplant for patients with multiple myeloma. If approved, will be the only drug approved for this indication.
- In a previous clinical study, Captisol-enabled melphalan met the requirements for establishment of bioequivalence to the current commercial intravenous formulation of melphalan.
Henderson, NV (Press Release) - Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations and a primary focus in hematology and …
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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.
