Articles tagged with: Revlimid

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[ by | Jul 23, 2014 2:56 pm | No Comment ]
The Myeloma Quiz – July 2014

It’s July, and we have had some time to digest the findings from the American Society of Clinical Oncology (ASCO) annual meeting held in Chicago May 30 through June 3.

Quite a few presentations caught one’s eye.

We finally saw the results of the much awaited PANORAMA-1 study in­ves­ti­gating the efficacy and safety of panobinostat (LBH589) plus Velcade and dexa­meth­a­sone compared to Velcade and dexamethasone alone.

Exciting data on the CD38 antibodies daratumumab and SAR650984 continued to emerge at ASCO.

Another study looked at …

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[ by | Jul 16, 2014 8:54 am | 35 Comments ]
Treatment Regimen Featuring Revlimid-Velcade-Dexamethasone Therapy And Stem Cell Transplantation Yields Deep Responses In Newly Diagnosed Multiple Myeloma

French researchers earlier this week published updated results of a small Phase 2 clinical trial testing the combination of Revlimid, Velcade, and dexa­metha­sone (RVD) in newly diagnosed multiple myeloma pa­tients.

The researchers found that RVD, when given before and after stem cell trans­plan­ta­tion – and when followed by maintenance therapy with Rev­limid – led to very deep treatment responses and significant survival rates.

The 31 newly diagnosed patients in the French trial initially were treated with three cycles of RVD therapy.  Next, the trial participants underwent autologous (own) stem cell …

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[ by | May 31, 2014 9:17 pm | One Comment ]
ASCO 2014 Multiple Myeloma Update – Day One

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 …

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[ by | May 15, 2014 1:01 pm | 5 Comments ]
Latest Myeloma Research To Be Presented At The American Society Of Clinical Oncology Annual Meeting (ASCO 2014)

The American Society of Clinical Oncology will hold its 50th annual meet­ing May 30 through June 3 in Chicago.

Similar to previous years, more than 25,000 physicians and researchers from all over the world are expected to attend the five-day meeting to dis­cuss the current research in cancer treatment and care.

During the meeting, there will be presentations about all areas of cancer, in­clud­ing many focused specifically on multiple myeloma. The ASCO website currently lists information about more than 60 myeloma-related studies (included under either the “multiple myeloma” or “

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[ by | Apr 26, 2014 1:56 am | One Comment ]

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.