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[ by Maike Haehle | May 31, 2014 9:17 pm | 3 Comments ]

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.

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[ by Navneet Ramesh and Julie Shilane | Mar 7, 2014 5:04 pm | 8 Comments ]

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 …

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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.