News

EMA accepts Kyprolis® marketing authorization application for the treatment of relapsed myeloma

Amgen and it’s subsidiary Onyx Pharmaceuticals Inc., have announced that the European Medicines Agency (EMA) has accepted their application for the marketing authorization of Kyprolis® (carfilzomib) as a treatment for relapsed myeloma patients who have received at least one previous line of treatment. The application, based on data from the Phase III ASPIRE trial comparing…

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FDA approves panobinostat as a treatment for myeloma

The US Food and Drug Administration (FDA) has approved the use of panobinostat for relapsed myeloma patients who have received at least two prior lines of treatment, including Velcade® and an immunomodulatory drug, making it the first histone deacetylase (HDAC) inhibitor to be approved for myeloma. Based on the overall results of the Phase III PANORAMA-1…

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FDA expands approval of Revlimid® to include newly diagnosed myeloma patients

The biopharmaceutical company, Celgene Corporation, has announced that both the European Commission and the US Food and Drug Administration (FDA) have expanded the existing indication for Revlimid in combination with dexamethasone to include its use as frontline treatment for newly diagnosed myeloma patients who are not eligible for high-dose therapy and stem cell transplantation. Revlimid…

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NICE issues second ‘no’ to pomalidomide

The National Institute for Health and Care Excellence (NICE), the drug approval body for England and Wales, has issued final draft guidance that does not recommend Imnovid (pomalidomide) as a treatment for myeloma patients after third or subsequent relapse. This second negative guidance is based on their opinion that the clinical benefit of Imnovid does…

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Interim data show ixazomib improves progression free survival in relapsed and/or refractory myeloma patients

The Japanese pharmaceutical company, Takeda, has announced positive data from the first interim analysis of its pivotal trial investigating ixazomib as a potential treatment for relapsed and/or refractory myeloma. The results showed a significant improvement in progression free survival in patients receiving ixazomib in combination with Revlimid and dexamethasone compared to those receiving Revlimid and…

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Novel genetic test receives conditional approval from FDA

Signal Genetics, the US-based molecular diagnostic company, has announced that its proprietary gene expression profiling (GEP) based test, Myeloma Prognostic Risk Signature® (MyPRS), has received conditional ‘Investigational Drug Exemption’ approval to assist with entry criteria for an upcoming clinical trial. The trial (2012-02 Total Therapy 5B), conducted at the University of Arkansas for Medical Sciences…

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Amgen submits applications in Europe and the US for the approval of Kyprolis® as a treatment for myeloma

Amgen and its subsidiary, Onyx Pharmaceuticals Inc., have announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Kyprolis (carfilzomib), seeking its approval as a treatment for relapsed myeloma patients who have received at least one prior treatment. In addition, a supplemental New Drug Application (sNDA) has been submitted…

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New IMWG consensus statement released on the use of MRI in myeloma

The International Myeloma Working Group (IMWG) has recently published a consensus statement in the Journal of Clinical Oncology recommending the use of magnetic resonance imaging (MRI) in myeloma. It recommends that all symptomatic and asymptomatic patients undergo whole-body MRI (or spinal and pelvic if whole-body MRI is not available) to detect bone marrow involvement and to…

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Results of Cancer Drugs Fund’s list reassessment announced

The results of a reassessment of the nationally approved list of drugs made available through the Cancer Drugs Fund (CDF) have been announced by NHS England. They confirm that Imnovid® (pomalidomide) for relapsed and refractory myeloma patients; Revlimid as a second-line treatment, and Velcade® as treatment for multiply relapsed Velcade-naive patients will remain on the list whereas…

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Orphan drug designation for novel drug selinexor as a treatment for myeloma

The US pharmaceutical company, Karyopharm Therapeutics Inc., has announced that the FDA has granted orphan drug designation for its lead drug candidate, selinexor (KPT-330), as a treatment for myeloma. This follows similar orphan drug designation granted recently by the European Medicines Agency (EMA). Selinexor is a first-in-class oral selective inhibitor of nuclear export which acts…

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