News

FDA approves new daratumumab combination for myeloma patients

Genmab and Janssen have announced that the US Food and Drug Administration (FDA) has expanded the approval of daratumumab (Darzalex®) as part of a treatment combination for relapsed and/or refractory myeloma patients. Currently licensed by the FDA for use as a monotherapy for patients who have received at least three previous treatments or in combination…

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NICE recommends carfilzomib for restricted use in England and Wales

The National Institute for Health and Care Excellence (NICE) has published a final appraisal determination (FAD) recommending the use of carfilzomib (Kyprolis®) in combination with dexamethasone for myeloma patients at first relapse who have not previously received bortezomib (Velcade®). Carfilzomib will immediately be available to eligible patients in England via interim funding arrangements through the…

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2017 ASCO preview

The abstracts for the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, released earlier this month, indicate that the main areas of interest in myeloma this year focus on novel treatment combinations including daratumumab (Darzalex®), other anti-CD38 antibodies, checkpoint inhibitors, pomalidomide (Imnovid®), carfilzomib (Kyprolis®) and venetoclax. In total, 84 abstracts on myeloma and related…

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IMWG publishes consensus on second primary malignancies in myeloma

The International Myeloma Working Group (IMWG) has published a consensus statement providing practical recommendations for managing myeloma patients who develop second primary malignanices (SPMs). Published in the Annals of Oncology, the group reviewed the latest evidence of possible host-, disease- and treatment-related risk factors for the development of SPMs in myeloma patients. They recommend that…

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New bi-specific monoclonal antibody to be tested 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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