News

Publication of data from daratumumab monotherapy trial

Data from the Phase I/II GEN-501 trial of daratumumab monotherapy have demonstrated encouraging efficacy and a favourable safety profile of the anti-CD38 monoclonal antibody in relapsed and/or refractory myeloma patients. Published in the New England Journal of Medicine, the results showed an overall response rate of 36% in patients who had had a median of…

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EMA accepts MAA for ixazomib as a treatment for myeloma

The Japanese pharmaceutical company, Takeda, has announced that the European Medicines Agency (EMA) has accepted its Marketing Authorisation Application (MAA) for the oral proteasone inhibitor, ixazomib, as a treatment for relapsed and/or refractory myeloma patients. The submission was primarily based on interim results from the pivotal Phase III TOURMALINE-MM1 comparing ixazomib in combination with Revlimid…

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NICE issues new draft guidelines for end of life care

The National Institute for Health and Care Excellence (NICE) has issued draft guidelines for consultation to improve the care of adults during the last few days of life. The guidelines are meant to replace the Liverpool Care Pathway which were phased out in 2014. Key recommendations highlight the importance of communication and shared decision-making involving…

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Study identifies recurrent gene mutations associated with high-risk myeloma

A study published recently in the Journal of Clinical Oncology has identified key copy number, structural abnormalities and mutations that interact and determine high-risk myeloma patients, thus paving the way for simple prognostic tests to be developed. The research, performed at The Institute of Cancer Research (ICR), London and funded by Myeloma UK, involved whole exome-sequencing…

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Novel fusion molecule granted US FDA Investigational Drug Approval as a treatment for myeloma

Mundipharma EDO GmbH, the “Early Developments in Oncology” arm of the Mundipharma network of independent associated companies, has announced that the US Food and Drug Administration (FDA) has accepted its Investigational New Drug Application for the drug candidate, EDO-S101, as a treatment for myeloma and other malignancies. EDO-S101 is a first-in-class fusion molecule of the alkylating…

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Publication of revised International Staging System for myeloma

The International Myeloma Working Group (IMWG) has revised the International Staging System (ISS) to enable better stratification of newly diagnosed myeloma patients. It now includes the detection of chromosomal abnormalities (CA) by interphase fluorescent in situ hybridisation (iFISH) and the measurement of serum lactate dehydrogenase (LDH) which, when combined with the previous ISS, provides powerful…

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EMA accepts market authorisation application for elotuzumab

Bristol-Myers Squibb and AbbVie have announced that the European Medicines Agency (EMA) has accepted the Market Authorisation Application (MAA) for their investigational drug, elotuzumab, as a treatment for relapsed myeloma patients who have had at least one previous line of treatment. Elotuzumab is a monoclonal antibody that targets the cell surface protein SLAM-7 found on…

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Carfilzomib receives expanded FDA approval

The US Food and Drug Administration (FDA) has expanded the indication for carfilzomib (Kyprolis®) to be used in combination with Revlimid and dexamethasone as a treatment for relapsed myeloma patients who have received at least one previous line of treatment. The approval was based on the results of the Phase III ASPIRE trial which showed…

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EMA grants accelerated assessment of ixazomib

Takeda, the Japanese pharmaceutical company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted an accelerated assessment of ixazomib as a treatment for relapsed and/or refractory myeloma patients. Ixazomib (previously known as MLN 9708) is an investigational oral proteasome inhibitor currently being studied in…

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