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Beacon NewsFlashes - April 26, 2014

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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.

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One Comment »

  • Nancy Shamanna said:

    Thanks for the three interesting news flashes, the first two of which are international in nature, and the third of which relates to a problem with the taking of high dose (HD) chemotherapy.

    As if melphalan were not harsh enough on one's system, to have to take it with propylene glycol also seems more harsh. It will be good if a better way of administering melphalan. There is also a connection here to the administration of Kyprolis.

    I don't think that Revlimid is approved for first line therapy in Canada either yet. Drugs have to be tested right up to the level of phase 3 trials, and also tested specifically to the use intended, before a government agency such as Health Canada would review them. If the drug's testing had been only done on relapsed patients, then it might be approved for relapsed patients. There doesn't seem to be much 'off label' use in countries with universal health care.

    It's good to hear that Velcade has been approved for first line therapy in the UK. I am sure that will help out a lot of patients. It certainly helped me a lot in my struggles with myeloma. I had it as a first line therapy, with dexamethasone.