News

Pivotal Phase III POLLUX trial results for Darzalex® published

Results from the pivotal Phase III POLLUX trial supporting the use of Darzalex (daratumumab) for relapsed and/or refractory myeloma patients have recently been published in the New England Journal of Medicine. Addition of Darzalex to Revlimid® (lenalidomide) and dexamethasone was shown to significantly improve the overall response rate as well as 12-month progression-free survival compared to…

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Results from Kyprolis® CLARION trial show no benefit over Velcade®

Amgen has released top line results from its Phase III head-to-head CLARION trial of Kyprolis (carfilzomib), melphalan and prednisolone (KMP) versus Velcade (bortezomib), melphalan and prednisolone (VMP) in newly diagnosed transplant ineligible myeloma patients. They show that the trial did not meet its primary end point of improved progression-free survival (PFS) with Kyprolis compared to…

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PharmaMar seeks European approval for Aplidin® as a treatment for myeloma

The Spanish biopharmaceutical company, PharmaMar, has announced it has submitted a Market Authorisation Application to the European Medicines Agency (EMA) for Aplidin (plitidepsin) to be used as a treatment for myeloma. Specifically, approval is being sought for Aplidin in combination with dexamethasone as a treatment for relapsed and/or refractory myeloma patients who have had at least…

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EMA recommends conditional approval for Ninlaro® in myeloma

Takeda has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended a conditional approval for Ninlaro (ixazomib) to be used as a treatment for relapsed and/or refractory myeloma patients who have received at least one previous line of treatment in combination with Revlimid® and dexamethasone. This follows…

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Kyprolis® turned down by Scottish Medicines Consortium

The Scottish Medicines Consortium (SMC) has decided not to recommended the use of Kyprolis (carfilzomib) as a treatment for myeloma patients in Scotland who have received at least one previous line of treatment. Kyprolis was considered for use in combination with Revlimid® and dexamethasone and although trial results showed improved progression free survival compared to…

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Selinexor shows promise in heavily pretreated myeloma patients

Karyopharm Therapeutics Inc. has recently released positive top-line results from its Phase IIb STORM trial showing promising response rates with the novel oral drug selinexor (KPT-330) in combination with dexamethasone for relapsed and refractory myeloma patients. Selinexor is the first in a new class of drugs known as Selective Inhibitor of Nuclear Export (SINE™) compounds…

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Amgen enters agreement to develop BiTE® immuno-oncology drug

Amgen has announced it has recently acquired the rights from Boehringer Ingelheim to clinically develop and commercialise the investigational drug BI 836909 as a potential treatment for myeloma. BI 836909 is a bispecific T cell engager (BiTE), a class of bispecific monoclonal antibodies which help engage T cells to tumour cells. It targets B-cell maturation antigen…

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Largest myeloma study opens for recruitment

The largest global observational study of its kind in myeloma has recently opened and is aiming to recruit 5,000 patients over three years in order to gain a better understanding of the real world experience of the disease. Sponsored by Takeda the study, called INSIGHT-MM, will follow myeloma patients from around the world for a…

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Study reveals prevalence of symptoms in myeloma patients

A Myeloma UK funded study, published recently in the European Journal of Haematology, has found that a large number of symptoms occur frequently in myeloma patients, highlighting the importance of routine assessments throughout the disease trajectory in order to achieve optimal quality of life for patients. Led by Christina Ramsenthaler and Prof Irene Higginson, Department of…

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New trial of novel drug DTP3 open for myeloma patients

A Phase I/IIa clinical trial investigating the safety, efficacy, pharmacokinetic and pharmacodynamic properties of a new drug, called DTP3, has recently opened for relapsed and/or refractory myeloma patients who have previously been treated with a proteasome inhibitor and an immunomodulatory drug. DTP3, originally developed by researchers at Imperial College, London, works by targeting the Gadd45β,…

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