News

New bi-specific monoclonal antibody to be trialled in myeloma

Glenmark Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application for its proprietary drug GBR 1342 to be investigated as a treatment for myeloma patients. GBR 1342 is a humanised bi-specific monoclonal antibody designed to activate the immune system by redirecting T cells to myeloma…

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EU approves expanded daratumumab indication for myeloma

Genmab and Janssen have announced that the European Commission has granted full approval for daratumumab (Darzalex®) to be used in combination with lenalidomide (Revlimid®) and dexamethasone, or bortezomib (Velcade®) and dexamethasome as a treatment for relapsed and/or refractory myeloma patients. This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use’s (CHMP)…

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NICE issues draft “no” on ixazomib as a treatment for myeloma patients

The National Institute for Health and Care Excellence (NICE) has issued draft negative guidance for ixazomib (Ninlaro®) in combination with lenalidomide (Revlimid®) as a treatment for relapsed and/or refractory myeloma patients who have received at least one previous line of treatment. Ixazomib, the first oral proteasome inhibitor to be made available, was granted a licence…

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Amgen seeks to expand denosumab indication to include myeloma

Amgen has announced it has submitted respective applications to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) to expand the currently approved indication for denosumab (Xgeva®) to include myeloma patients. At present, denosumab is licensed for the prevention of skeletal-related events (SREs) in solid cancer patients but results from a recent…

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Myeloma XII opens for recruitment

The latest national myeloma trial, Myeloma XII, has recently opened for patient recruitment. The aim of this Phase III trial is to determine whether ixazomib (Ninlaro®) has a significant impact on the depth and duration of response when used as an augmented conditioning treatment in salvage autologous stem cell transplantation (ASCT) and then as post-transplant…

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FDA places partial clinical hold on all selinexor trials

The US Food and Drug Administration (FDA) has placed a partial hold on all clinical trials involving selinexor according to Karyopharm Therapeutics, the company developing the drug. Selinexor is the first in a new class of drugs known as Selective Inhibitor of Nuclear Export (SINE™) compounds which by inhibiting XPO-1 mediated nuclear-cytoplasmic protein transport, causes…

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NICE issues draft “no” on daratumumab monotherapy

The National Institute for Health and Care Excellence (NICE) has issued draft negative guidance for daratumumab (Darzalex®) monotherapy as a treatment for relapsed and refractory myeloma patients. Although daratumumab monotherapy was granted a licence by the European Medicines Agency (EMA) based on results of two Phase II trials, the degree of uncertainty for the clinical…

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Experimental drug stimulates the immune system against myeloma

A study, published recently in Nature Medicine, has demonstrated that the experimental drug LCL-161 causes robust anti-myeloma activity through stimulation of the immune system. LCL-161 is a small-molecule inhibitor of apoptosis (IAP) which was originally developed to promote tumour cell death via apoptosis. However, in this study robust anti-myeloma activity was observed via upregulation of…

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