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Highlights from ASCO and EHA 2016

Highlights of key data presented at the 2016 Annual Meeting of the American Society of Clinical Oncology (ASCO) held recently in Chicago and the 21st Congress of the European Hematology Association (EHA) in Copenhagen, Denmark, included: Initial results of the Phase III CASTOR trial showing that addition of the anti-CD38 monoclonal antbody Darzalex® (daratumumab) to…

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Abingdon Health and Sebia join forces to distribute Seralite®-FLC globally

The medical diagnostics companies Abingdon Health and Sebia have announced that they have entered into an agreement to enable the global distribution of Seralite-FLC, a rapid diagnostic device for the quantitative measurement of kappa and lambda immunoglobulin free light chains originally developed by Abingdon Heath. Seralite-FLC enables the diagnosis and monitoring of plasma cell disorders,…

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Study identifies the mechanism of action of thalidomide and other IMiDs

A study published recently in Nature Medicine has identified further cellular targets by which thalidomide and other immunomodulatory drugs (IMiDs) exert their anti-cancer and teratogenic effects, which could lead to the development of more effective treatments for myeloma with a lower risk of causing adverse effects especially severe birth defects. The researchers found that the…

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Study shows that myeloma may be linked to pesticide exposure

An analysis of results from three case control studies in North America involving more than 3,200 people has shown that exposure to certain types of pesticides is associated with an increased risk for the development of myeloma in men. Using data from 547 myeloma patients and 2700 healthy participants, the researchers found that any exposure,…

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EMA recommends expanding Kyprolis® indication for myeloma

Amgen has recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended extending the current indication for Kyprolis (carfilzomib) to include its use as a treatment in combination with dexamethasone for relapsed myeloma patients who have received at least one previous line of treatment. Kyprolis is…

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EMA says ‘no’ to Ninlaro®

Takeda, the Japanese pharmaceutical company, has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion recommending against the approval of Ninlaro (ixazomib) as a treatment for relapsed and/or refractory myeloma who have received at least one previous line of treatment. Ninlaro is the first…

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Darzalex® approved in Europe for relapsed and refractory myeloma patients

Genmab and Janssen have announced that the European Commission has granted a licence for the use of Darzalex (daratumumab) monotherapy as a treatment for relapsed and refractory myeloma patients whose previous treatments have included a proteasome inhibitor and an immunomodulatory drug, and who have demonstrated disease progression on their last treatment. Based on results from…

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Pivotal Phase III trial results for Ninlaro® published

Results from the pivotal Phase III TOURMALINE-MM1 trial supporting the use of Ninlaro (ixazomib) for relapsed and/or refractory myeloma patients have been published recently in the New England Journal of Medicine. Ninlaro is the first oral proteasome inhibitor to be developed for myeloma and its recent approval by the US Food and Drug Administration (FDA)…

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Empliciti® approved in Europe for relapsed myeloma patients

Bristol-Myers Squibb and AbbVie have announced that the European Commission has approved Empliciti (elotuzumab) as a treatment for myeloma patients who have received at least one previous treatment. Based on data from the Phase III ELOQUENT-2 trial, Empliciti is licensed for use in combination with Revlimid® (lenalidomide) and dexamethasone. It becomes the first immunostimulatory monoclonal…

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