HEMEL HEMPSTEAD, United Kingdom and BURLINGTON, Massachusetts – 25th February 2021
EUSA Pharma (UK) Limited (“EUSA Pharma”), a global biopharmaceutical company focused on oncology and rare diseases, announced that the National Comprehensive Cancer Network® (NCCN®) has updated their Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas to include siltuximab (SYLVANT®) as the preferred primary treatment for patients with human immunodeficiency virus–negative [HIV(-)] and human herpesvirus 8–negative [HHV-8(-)] multicentric Castleman disease (MCD), also known as idiopathic multicentric Castleman disease (iMCD), regardless of histopathologic subtype.1 Siltuximab is currently approved in more than 40 countries worldwide for the treatment of all histopathologic subtypes of iMCD, a rare, life-threatening and debilitating orphan condition of the lymph nodes and related tissues.2,3 The update is based on a 2020 publication which demonstrated that there is insufficient evidence to guide treatment based solely on lymph node histopathologic subtype.4
Lee Morley, Chief Executive Officer, EUSA Pharma, said, “We are delighted that the NCCN has recognised the importance of siltuximab in treating iMCD. As the only FDA-approved therapy indicated for this patient population, the change in the NCCN Guidelines® means that even more patients will be able to benefit.”
Dr David Fajgenbaum, MD, MBA, MSc, Assistant Professor of Medicine, Translational Medicine & Human Genetics, University of Pennsylvania and Co-Founder & Executive Director, Castleman Disease Collaborative Network (CDCN) said, “As a patient with iMCD and a researcher focused on advancing effective treatments for iMCD, I am really pleased to see that the NCCN has updated their iMCD treatment Guidelines to align with FDA and EC approvals and evidence-based recommendations from the Castleman Disease Collaborative Network. This is a significant step forward, but we have important work ahead to ensure that all iMCD patients are able to receive treatments that help them to live full lives after their diagnosis.”
Siltuximab is a monoclonal antibody that directly neutralises IL-6, an inflammatory cytokine detected at elevated levels in multiple inflammatory conditions. SYLVANT® (siltuximab) is currently approved by the US Food and Drug Administration (FDA) and the European Commission (EC), as well as regulatory authorities in several other jurisdictions worldwide, for the treatment of adult patients with multicentric Castleman disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Indications and Usage – See EMA Summary of Product Characteristics (SmPC) and FDA Prescribing Information for additional information.
About EUSA Pharma
Founded in March 2015, EUSA Pharma is a world-class biopharmaceutical company focused on oncology and rare disease. The company is headquartered in Hemel Hempstead, England (UK), and has extensive commercial operations in the United States and Europe, alongside a direct presence in selected other markets across the globe. EUSA Pharma is led by an experienced management team with a strong record of building successful pharmaceutical companies, and it is supported by significant funding raised from leading life science investor EW Healthcare Partners. For more information, please visit www.eusapharma.com.
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1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas Version 2.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed [February 25, 2021]. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
2. SYLVANT® (package insert – available here). Hertfordshire, UK: EUSA Pharma UK Ltd; 2019.
3. Fajgenbaum, D.C., et al. International, evidence-based consensus diagnostic criteria for HHV-8–negative/idiopathic multicentric Castleman disease. Blood. 2017;129(12):1646-1657. doi: 10.1182/blood-2016-10-746933.
4. Fajgenbaum, D.C., et al. Insufficient evidence exists to use histopathologic subtype to guide treatment of idiopathic multicentric Castleman disease, American Journal of Hematology. 2020;95(12): 1153-1561. doi: 10.1002/ajh.25992.