News

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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Study identifies genetic link to Velcade®-induced peripheral neuropathy

A study, published recently in Clinical Cancer Research, has found that myeloma patients may be genetically predisposed to Velcade-induced peripheral neuropathy. Researchers carried out a genome-wide association study (GWAS) of over 370,000 single nucleotide polymorphisms (SNPs) in 469 myeloma patients treated with Velcade and dexamethasone prior to high-dose therapy and autologous stem cell transplantation in…

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Trial of plitidepsin for relapsed and/or refractory myeloma patients meets primary endpoint

PharmaMar, the Spanish biopharmaceutical company, has announced that results from its Phase III ADMYRE trial of plitidepsin (Aplidin) in combination with dexamethasone have demonstrated a significant reduction in the risk of disease progression or death compared to treatment with dexamethasone alone. Plitidepsin is a novel anticancer drug of marine origin originally extracted from the ascidian…

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Revlimid® approved in Northern Ireland for restricted use in newly diagnosed myeloma patients

The Health and Social Care Board in Northern Ireland has approved Revlimid (lenalidomide) for restricted use in newly diagnosed myeloma patients who are not eligible for high-dose therapy and stem cell transplantation. It is now available in combination with dexamethasone in this setting for patients who are contraindicated to thalidomide because of existing peripheral neuropathy.…

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EMA recommends Darzalex® as a treatment for myeloma

The Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) has granted a positive recommendation for the use of single-agent Darzalex (daratumumab) as a treatment for relapsed and refractory myeloma patients who have previously received a proteasome inhibitor and an immunomodulatory drug and who have demonstrated disease progression on their…

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Darzalex® and atezolizumab combination to be investigated in myeloma

The pharmaceutical companies, Janssen and Genentech, have announced they are collaborating to determine the safety and effectiveness of the monoclonal antibody Darzalex (daratumumab) in combination with the checkpoint inhibitor atezolizumab as a treatment for relapsed and/or refractory myeloma and for solid tumours. Additional studies will also be performed to include a triplet combination of atezolizumab,…

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New melphalan formulation gains FDA approval

Spectrum Pharmaceuticals, the American biotechnology company, has announced that the US Food and Drug Administration (FDA) has approved the use of its product Evomela® for two indications in myeloma. Evomela is a novel intravenous formulation of melphalan that incorporates the use of the Captisol®-enabled technology which enhances the stability of melphalan and eliminates the use of…

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Updated IMWG recommendations for the diagnosis and management of myeloma-related renal impairment

The International Myeloma Working Group (IMWG) has published updated recommendations for the diagnosis and management of myeloma-related renal impairment. They recommend that all patients should be assessed for renal impairment at diagnosis and at every follow-up visit including serum creatinine measurement, estimated glomerular filtration rate, electrolyte measurement, and if available, free light chain as well…

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Vorinostat and Velcade combination active in refractory myeloma patients

Data from the global multi-centre Phase IIb VANTAGE 095 trial have demonstrated that the histone deacetylase inhibitor, vorinostat, in combination with Velcade is effective in myeloma patients who are considered to be refractory to conventional anti-myeloma treatment. Published recently in Clinical Lymphoma Myeloma & Leukemia, the results showed an objective response rate of 11.3%, median…

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MUK seven opens for recruitment

Myeloma UK is pleased to announce that MUK seven is the latest trial in the Myeloma UK Clinical Trial Network (CTN) to open for patient recruitment. MUK seven, a Phase II randomised trial, is determining whether the addition of cyclophosphamide to Imnovid® (pomalidomide) and dexamethasone improves progression free survival in relapsed and/or refractory myeloma patients compared…

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