News

Pivotal head-to-head trial shows benefit of Kyprolis® over Velcade®

The results of the first head-to-head Phase III trial comparing two proteasome inhibitors, have demonstrated the benefits of Kyprolis over Velcade for relapsed and/or refractory myeloma patients. Published online in the Lancet Oncology, the ENDEAVOR trial compared outcomes for 929 patients randomised to receive either Kyprolis and low-dose dexamethasone (Kd) or Velcade and low-dose dexamethasone (Vd),…

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NICE recommends use of Farydak® for myeloma patients

The National Institute for Health and Care Excellence (NICE) has recommended the use of Farydak (panobinostat) as a treatment for relapsed and/or refractory myeloma patients who have received at least two previous lines of treatment including Velcade® (bortezomib) and an immunomodulatory drug. This comes after an initial negative guidance issued in September which has now…

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FDA approves Empliciti® (elotuzumab) as a treatment for myeloma

Bristol-Myers Squibb and AbbVie have announced that the US Food and Drug Administration (FDA) has approved the use of Empliciti in combination with Revlimid® and dexamethasone (ERd) as a treatment for relapsed myeloma patients who have received between one to three previous lines of treatment. The approval is based on data from the Phase III ELOQUENT-2…

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New virotherapy trial involving Reolysin® opens for myeloma patients

The Canadian biotechnology company, Oncolytics Biotech. Inc., has recently opened a Phase 1b trial of its proprietary drug Reolysin in combination with Velcade® and dexamethasone for relapsed and/or refractory myeloma patients. Reolysin is a variant of the reovirus (Respiratory Enteric Orphan Virus) that is known to infect and selectively destroy cancer cell, particularly those with…

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Ninlaro® (ixazomib) approved by FDA as a treatment for myeloma

Takeda, the Japanese pharmaceutical company, has announced that the US Food and Drug Administration (FDA) has approved the use of ixazomib as a treatment for relapsed myeloma patients who have received at least one prior line of treatment. Ixazomib is the first, and currently only oral proteasome inhibitor, to be licensed and is indicated for…

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Kyprolis® approved in Europe for relapsed myeloma patients

The European Commission has approved the use of Kyprolis (carfilzomib) in combination with Revlimid® and dexamethasone as a treatment for relapsed myeloma patients who have received at least one previous line of treatment. This follows the recent recommendation by the European Medicines Agency (EMA) based on the pivotal ASPIRE trial which showed that Kyprolis in…

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FDA approves Darzalex® (daratumumab) as a treatment for myeloma

Genmab, the Danish biotechnology company, and its collaborative partner, Janssen Biotech Inc., have announced that the US Food and Drug Administration (FDA) has approved the use of daratumumab as a treatment for relapsed and/or refractory myeloma patients who have received at least three previous lines of treatment including a proteasome inhibitor (PI) and an immunomodulatory…

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FDA rejects new drug application for use of captisol-enabled melphalan in myeloma

Spectrum Pharmaceuticals, the US commercial-based biotechnology company, has announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter declining the approval of its drug captisol-enabled melphalan (Evomela™) in its current form for use as a treatment for myeloma patients. Evomela is a propylene glycol-free formulation which uses Captisol® technology to reformulate melphalan…

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