|Vol.1 Issue 6||gman.myeloma.org||October 2015|
European Medicines Agency Validates and Grants Accelerated Assessment of Marketing Authorization Application for Empliciti (elotuzumab)
On July 27th, the European Medicines Agency (EMA) validated for review the marketing authorization application for elotuzumab for the treatment of multiple myeloma for patients who have received one or more prior therapies. Additionally, on August 31, the US Food and Drug Administration (FDA) accepted for priority review the Biologics License Application for elotuzumab. Elotuzumab is an investigational antibody targeting Signaling Lymphocytic Activation Molecule Family member 7 (SLAMF7), a protein that is found on the surface of myeloma cells but is not detectable in normal tissue. The investigational drug previously obtained orphan drug designation in the EU. For more information, click here.
GMAN Working Group Meets in Rome
On September 22nd fifteen member groups of GMAN met in Rome for a workshop on sustainability of organizations. Guest speaker Prof. Jean-Luc Harousseau, a 2009 Robert A. Kyle award winner, addressed the group on the increasing cost of treatment for myeloma. Sofia Cardoso of ACPL (Portugal) presented a multitude of fundraising tips, tricks and pointers that were well received. Based on prior member feedback, participants were separated into small groups to discuss and exchange ideas on succession planning, educational materials, social media, and other topics. Each group then shared their learnings with the full group. GMAN is currently looking at other focus areas in which to create additional workshops. Notes from this meeting will be available via the member portal later this month. Members will be notified by email.
Patient Safety Threatened in Paraguay
As a follow-up on our report from last month, patients in Paraguay continue to await an update on rules governing the sale of drugs in the country that have remained in place since 2011. Currently with synthetic pharmaceuticals, no regulatory distinction is made between copies and the original drug, creating an uncertain situation for patients when filling prescriptions as to which version they receive. With the advent of biosimilars, the dangers of poor quality and varying dosage in off brand manufacturers are enhanced. Biosimilars are more complex, require more stringent quality control protocols, and are harder to accurately reproduce, yet fall under the same regulatory framework as synthetics when it comes to copies. Several patient advocacy groups are concerned with the potential health risks inherent to such a lack of regulation and have pushed for a solution closely aligned with the World Health Organization’s (WHO) recommended guidelines on biosimilars, which can be found here. Fundación Unidos contra el Cáncer (FUNCA) and other groups continue to voice their concerns and push for updates to existing rules. For more information or to learn how your group can help, contact Gabriela Simancas, FUNCA, through the chat forum here.
To submit a news story for publication, please contact
Raymond Wezik, Global Advocacy Executive, International Myeloma Foundation at [email protected].