News

Investigational new drug applications submitted to FDA

Two investigational new drug (IND) applications have been submitted to the U.S. Food and Drug Administration (FDA) this month. The biopharmaceutical company, Kite Pharma, have submitted an IND application to set up a Phase I trial to test KITE-585 for relapsed and/or refractory myeloma. KITE-585 is a CAR-T cell therapy that targets B-cell maturation antigen…

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Genmab report positive results from Phase III daratumumab trial for myeloma patients

The Danish biotechnology company, Genmab, have announced that the Phase III trial, ALCYONE, has achieved its primary endpoint of improving progression-free survival in newly diagnosed myeloma patients. This study compared daratumumab (Darzalex®) in combination with bortezomib (Velcade®), melphalan and prednisone (VMP) to VMP alone. Treatment including daratumumab was demonstrated to reduce the risk of disease…

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Carfilzomib combination approved for use in Scotland

The Scottish Medicines Consortium (SMC) has approved the use of carfilzomib (Kyprolis®) in combination with dexamethasone for myeloma patients who have received at least one previous treatment. The approval is based on results from the ENDEAVOR trial which showed that progression-free survival was significantly improved in patients treated with carfilzomib in combination with dexamethasone compared…

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Lenalidomide maintenance treatment demonstrates significant overall survival benefit following HDT-ASCT

Meta-analysis of results from three randomised control trials has demonstrated that maintenance treatment with lenalidomide (Revlimid®) following high-dose therapy and autologous stem cell transplantation (HDT-ASCT) in newly diagnosed myeloma patients has a significant overall survival (OS) benefit. Published in the Journal of Clinical Oncology, the results of this meta-analysis, which used data pooled from the…

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SKY92 validated as a useful prognostic tool for myeloma patients

A study, published recently in Clinical Lymphoma, Myeloma and Leukemia, has further validated the use of the SKY92 gene expression signature as a potentially valuable prognostic tool to evaluate myeloma patients. Compared with seven other gene expression profiling classifiers including UAMS 70, UAMS 80 and IFM15, the researchers found that SKY92 identified the largest proportion (21%)…

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Publication of new guidelines for imaging myeloma patients in the UK

Myeloma UK together with expert haematologists and radiologists have jointly published new British Society of Haematology (BSH) guidelines for the use of imaging in the diagnosis and management of myeloma patients. This comes following the recent recommendations made by The International Myeloma Working Group (IMWG) and The National Institute for Health and Care Excellence (NICE)…

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Pembrolizumab trials in myeloma suspended

The US pharmaceutical company, Merck, has announced that three of its trials (KEYNOTE-183, KEYNOTE-185 and KEYNOTE-023) investigating pembrolizumab (Keytruda®) treatment combinations for myeloma patients have all been placed on clinical hold. Based on the available data, the US Food and Drug Administration (FDA) has determined that the risks of pembrolizumab treatment combinations outweigh any potential…

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Publication of consensus statement on the use of plerixafor in myeloma or lymphoma patients

A consensus statement identifying the best use of plerixafor to facilitate autologous peripheral stem cell collection to support high-dose therapy and stem cell transplantation in myeloma or lymphoma patients has been published recently in the Journal of Clinical Apheresis. Written by the Plerixafor Usage Working Party Group involving representative clinicians from the UK and Republic…

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