Myeloma UK news

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Myeloma UK news
Kyprolis® approved in Europe for relapsed myeloma patients
The European Commission has approved the use of Kyprolis (carfilzomib) in combination with Revlimid® (lenalidomide) 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 combination with Revlimid and dexamethasone significantly enhanced progression free survival compared to Revlimid and dexamethasone alone (26.3 vs 17.6 months respectively). Kyprolis is currently being appraised by the National Institute for Health and Care Excellence (NICE) for routine use in the UK. Final guidance is expected in September 2016.
http://www.amgen.com/media/news-release ... e-myeloma/

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 drug (IMiD). Daratumumab is the first monoclonal antibody to be approved for myeloma, based on the pivotal Phase II SIRIUS (MMY2002) trial which reported single agent activity, generating an overall response rate of 29.2% and a median duration of response of 7.4 months, in heavily pretreated patients. The current indication has been awarded under accelerated approval based on response rate and continued approval may be contingent on further trial data. Daratumumab will be referred to by its brand name Darzalex®. It is currently being assessed by the European Medicines Agency (EMA) where a decision is expected in mid-2016.
http://ir.genmab.com/releasedetail.cfm?ReleaseID=942957

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 use in combination with Revlimid® and dexamethasone. The approval is based on results of the Phase III TOURMALINE-MM1 trial which showed that patients treated with ixazomib, Revlimid and dexamethasone significantly extended progression free survival compared to patients treated with Revlimid and dexamethasone alone. The drug is being marketed under the brand name, Ninlaro®.
http://investor.millennium.com/phoenix. ... highlight=

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 one or more mutations in the RAS signalling pathway. Such cells have an aberrant antiviral response and are unable to prevent the virus from replicating, allowing it to multiply to an extent that is fatal to the infected cell. The trial is aiming to evaluate the safety, optimum dose and efficacy of Reolysin when given alongside Velcade and dexamethasone.
http://www.oncolyticsbiotech.com/news/p ... fault.aspx

Leuk Lymphoma. 2015 Nov 23:1-17. [Epub ahead of print]
Optimal use of bendamustine in hematologic disorders: Treatment recommendations from an international consensus panel - an update.
http://www.ncbi.nlm.nih.gov/pubmed/26592922