News

Orphan grant awarded to ONC201 trial for myeloma

The U.S. Food  and Drug Administration has awarded an orphan grant to the novel drug, ONC201, thereby furthering its clinical development through a Phase II trial for relapsed and/or refractory myeloma patients. ONC201 is an orally bioavailable inhibitor of Akt and ERK and has previously demonstrated promising anti-tumor activity in various pre-clinical models of refractory…

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Expanded use for Darzalex® sought in Europe

Genmab and Janssen have announced they have submitted an application to the European Medicines Agency (EMA) to expand the scope of Darzalex (daratumumab) as a treatment for myeloma. Currently licensed as a monotherapy for relapsed and refractory myeloma patients, the latest submission based on data from two Phase III trials, POLLUX and CASTOR,  is seeking…

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Revamped Cancer Drugs Fund launched in England

A revised Cancer Drugs Fund (CDF) together with wider changes in the way the National Institute for Health and Care Excellence (NICE) assesses cancer drugs has recently been launched. Developed through a partnership between National Health Service (NHS) England and NICE, the new CDF allows drugs which meet set criteria under a managed access agreement…

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IMWG publishes updated consensus criteria for response and MRD in myeloma

The International Myeloma Working Group (IMWG) has recently published further consensus criteria for defining disease response in myeloma. Since the original response criteria were set in 2006, newer, more sensitive methods can now quantify myeloma cells as low as 1 in a million. Published in the Lancet Oncology, the updated criteria identify responses beyond complete response…

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New genetic clues help explain inherited predisposition to myeloma

A study published recently in Nature Communications has identified eight new genetic risk loci for myeloma, providing further insights into the genetic and biological basis of its predisposition. The research, performed at The Institute of Cancer Research (ICR) and part funded by Myeloma UK involved a meta-analysis of pooled data from several independent genome-wide association…

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Second FDA breakthrough therapy designation for Darzalex®

The pharmaceutical companies Genmab and Janssen have recently announced that the US Food and Drug Administration (FDA) has granted a second breakthrough therapy designation for their anti-CD38 monoclonal antibody Darzalex® (darartumumab). This latest breakthrough therapy designation was granted on the basis of results from the two Phase III POLLUX and CASTOR trials and is looking to…

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PADI2 expression linked with progression of MGUS to myeloma

A study published recently in Leukemia has revealed that over expression of peptidyl arginine deiminase 2 (PADI2) enzyme in bone marrow mesenchymal cells is associated with the progression of monoclonal gammopathy of undetermined significance (MGUS) to myeloma. Researchers from University of Birmingham found that this led to an increased production of interleukin-6, a key cytokine…

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European Commission approves extended indication for Kyprolis®

Amgen has recently announced that the European Commission has approved the extended indication for Kyprolis (carfilzomib) which now includes its use as a treatment in combination with dexamethasone for relapsed myeloma patients who have received at least one previous line of treatment. The decision is based on data from the Phase III ENDEAVOR trial in…

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Launch of new journal “Myeloid and Lymphoid disorders in practice” 

A new journal Myeloid and Lymphoid disorders in practice, a free publication offering opinion, guidance, practical advice and updates on the latest thinking in haematological disorders is now available in print and online. It features a variety of review-based articles commissioned from leading experts, relevant to all members of the multidisciplinary team involved in the diagnosis treatment…

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