News

New drug application for Captisol-enabled® melphalan submitted to FDA

Ligand Pharmaceuticals Inc., the US pharmaceutical company, has announced that it’s partner Spectrum Pharmaceuticals has submitted a new drug application (NDA) to the FDA for Captisol-enabled melphalan as a new treatment for myeloma. Captisol-enabled melphalan is a novel intravenous formulation of the chemotherapy agent that eliminates the use of propylene glycol, thereby reducing the risk…

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Imnovid® approved for use in Scotland

The Scottish Medicines Consortium (SMC) has today accepted the use of Imnovid (pomalidomide) in combination with dexamethasone for the treatment of relapsed and refractory myeloma in patients who have received at least two prior treatments, including Velcade® (bortezomib) and Revlimid® (lenalidomide), and who have evidence of disease progression following their last treatment. The approval follows…

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Publication of data from the Kyprolis® Phase III ASPIRE trial

Results of the Phase III ASPIRE trial comparing the treatment of relapsed myeloma patients with Kyprolis (carfilzomib), Revlimid and dexamethasone versus Revlimid and dexamethasone have demonstrated that addition of Kyprolis to Revlimid and dexamethasone generated deep and durable responses, and increased progression free survival (PFS). Published in the New England Journal of Medicine, the results showed that PFS was significantly improved with…

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Orphan drug designation for novel drug I-131-CLR1404 as a treatment for myeloma

The US biopharmaceutical company, Cellectar Biosciences, has announced that the FDA has granted orphan drug designation for its proprietary drug, I-131-CLR1404, as a treatment for myeloma. I-131-CLR1404 is a small molecule, broad-spectrum radiopharmaceutical comprised of a unique optimised phospholipid ether (PLE) analogue that acts as a cancer-targeted delivery and retention vehicle. Orphan drug status will support the company’s…

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Ixazomib granted FDA breakthrough therapy status for the treatment of relapsed or refractory AL amyloidosis

Takeda, the Japanese pharmaceutical company, has announced its investigational drug ixazomib (MLN 9708) has been granted breakthrough therapy status by the US Food and Drug Administration (FDA) for the treatment of relapsed or refractory AL amyloidosis. Ixazomib is an oral proteasome inhibitor which in early clinical trials has shown promise in heavily pretreated AL amyloidosis patients. This is the…

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Phase II trial of daratumumab for smouldering myeloma planned

Genmab, the Danish biotechnology company, has announced that its collaborative partner, Janssen Biotech, Inc. will be starting a Phase II trial of daratumumab in smouldering myeloma. The trial is expected to recruit 120 high-risk patients to investigate whether early treatment with the anti-CD38 monoclonal antibody can extend the period before disease progression to symptomatic myeloma. Patients will be randomised…

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FDA extends review period for approval application of panobinostat as a treatment for myeloma

Novartis, the Swiss multinational pharmaceutical company, has announced the US Food and Drug Administration (FDA) has extended the review period for the approval application of its drug panobinostat as a potential new treatment for myeloma. This comes after the FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended against its approval earlier this month with concerns about the safety of the drug and reliability…

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Anti-myeloma drugs to be re-evaluated for Cancer Drugs Fund

Major changes to the operation of the National Cancer Drugs Fund (CDF) have been announced in an attempt to maintain the sustainability of the system. These include the re-evaluation of several drugs currently available via the CDF, together with an assessment of a drug’s cost alongside its clinical benefit. Pomalidomide for relapsed and refractory myeloma patients, together with Velcade® and…

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Preliminary ‘no’ from FDA regarding panobinostat approval application

The Oncology Drugs Advisory Committee (ODAC) of the US Food and Drugs Administration (FDA) has recommended against approving panobinostat as a treatment for myeloma. Data from the PANORAMA-1 trial of panobinostat in combination with bortezomib and dexamethasone in relapsed and/or refractory patients was used to support the application but members of the ODAC committee expressed…

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Novel IL-15 super agonist investigated for the treatment of relapsed or refractory myeloma

The US biopharmaceutical company, Altor Bioscience, has announced it has started a Phase I/II trial of its proprietary drug ALT 803 for relapsed and/or refractory myeloma patients who have had at least two prior treatments. ALT 803 is a novel interleukin-15 (IL-15) super agonist which has been shown to simultaneously activate both the innate and adaptive arms of the immune…

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