Beacon NewsFlashes - April 26, 2014
Published: Apr 26, 2014 1:56 am
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.