Press Release : FDA grants Breakthrough Device Designation for Roche's Elecsys Growth Differentiation Factor-15 (GDF-15) assay to help identify patients suitable for innovative treatment addressing unintentional weight loss in cancer patients

 
   -- FDA BDD acknowledges the importance of GDF-15 testing in identifying 
      eligible cachexic patients with solid tumours to be treated with Pfizer's 
      investigational drug PF-06946860 
 
   -- Unintentional weight loss (cachexia) is a highly prevalent complication 
      of cancer, affecting more than half of all cancer patients worldwide, 
      potentially leading to significant functional impairment and increased 
      risk of death 
 
   -- Successful cachexia treatment can potentially contribute to improved 
      cancer treatment worldwide 
 
 
   Basel, 8 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced 
today that the U.S. Food and Drug Administration (FDA) has granted 
Breakthrough Device Designation to their Elecsys(R) GDF-15 assay as a 
companion diagnostic (CDx) in cancer treatment. This in vitro diagnostic 
immunoassay is intended for measurement of Growth Differentiation 
Factor-15 (GDF-15) in cachectic patients 18 years of age and older with 
solid tumours for treatment with Pfizer Inc.'s (NYSE: PFE) 
investigational drug PF-06946860. 
 
   Cachexia is a metabolic disorder and comorbidity that occurs with 
several chronic diseases including cancer, heart failure, chronic 
obstructive pulmonary disease (COPD), and chronic kidney disease (CKD). 
It impacts more than 30 million people globally. Cachexia manifests as 
marked involuntary body weight loss, muscle atrophy, and reduced 
appetite, progressing to significant functional impairment and increased 
risk of death.(1) Elevated GDF-15 is associated with cachexia in cancer 
patients. Cachexia is a highly prevalent complication of cancer, 
affecting between 50 to 80% of all cancer patients. This range depends 
on the tumour type, the patient response to tumour progression and on 
individual body type.(2) 
 
   "We are pleased to partner with Pfizer to address this unmet medical 
need in oncology through strong companion diagnostics", said Thomas 
Schinecker, CEO Roche Diagnostics. "The FDA BDD grant for the Elecsys 
GDF-15 assay shows the importance of these strong partnerships. The 
ability to detect elevated GDF-15 in patients who are experiencing 
weight loss may provide a precision-medicine approach to identifying 
patients likely to respond to a GDF-15 therapeutic treatment." 
 
   About Elecsys GDF-15 
 
   Elecsys GDF-15 is a quantitative serologic, two-incubation step 
electrochemiluminescence immunoassay (ECLIA) using the sandwich test 
format for the detection of GDF-15 in human serum. The Elecsys GDF-15 
assay is indicated as an aid in identifying cachectic patients 18 years 
of age and older with solid tumours for treatment with PF-06946860. The 
electrochemiluminescence immunoassay "ECLIA" is intended for use on 
cobas e immunoassay analyzers. GDF-15 has CE approval in several 
intended uses in cardiology including risk prediction of major bleeding 
events of atrial fibrillation patients, risk stratification of patients 
with acute coronary syndrome or chronic heart failure. 
 
   About Cachexia 
 
   Cachexia impacts more than 30 million people globally but is poorly 
understood due to its complexity. It has traditionally been seen as a 
complication of chronic diseases or end stages of cancer. The burden 
cachexia poses on patients, their caregivers and loved ones, as well as 
the healthcare system, is significant. Cancer cachectic patients 
experience numerous complications including, but not limited to, reduced 
effectiveness of chemotherapy, reduced mobility and reduced 
functionality of muscle-dependent systems, such as the respiratory and 
cardiovascular systems, leading to decreased quality of life and 
survival. 
 
 
 
   About Roche 
 
   Roche is a global pioneer in pharmaceuticals and diagnostics focused on 
advancing science to improve people's lives. The combined strengths of 
pharmaceuticals and diagnostics under one roof have made Roche the 
leader in personalised healthcare -- a strategy that aims to fit the 
right treatment to each patient in the best way possible. 
 
 
 
   Roche is the world's largest biotech company, with truly differentiated 
medicines in oncology, immunology, infectious diseases, ophthalmology 
and diseases of the central nervous system. Roche is also the world 
leader in in vitro diagnostics and tissue-based cancer diagnostics, and 
a frontrunner in diabetes management. 
 
 
 
   Founded in 1896, Roche continues to search for better ways to prevent, 
diagnose and treat diseases and make a sustainable contribution to 
society. The company also aims to improve patient access to medical 
innovations by working with all relevant stakeholders. More than thirty 
medicines developed by Roche are included in the World Health 
Organization Model Lists of Essential Medicines, among them life-saving 
antibiotics, antimalarials and cancer medicines. Moreover, for the 
twelfth consecutive year, Roche has been recognised as one of the most 
sustainable companies in the Pharmaceuticals Industry by the Dow Jones 
Sustainability Indices (DJSI). 
 
 
 
   The Roche Group, headquartered in Basel, Switzerland, is active in over 
100 countries and in 2020 employed more than 100,000 people worldwide. 
In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 
58.3 billion. Genentech, in the United States, is a wholly owned member 
of the Roche Group. Roche is the majority shareholder in Chugai 
Pharmaceutical, Japan. For more information, please visit 
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www.roche.com. 
 
 
 
   All trademarks used or mentioned in this release are protected by law. 
 
 
 
 
 
 
 
   References 
 
   [1] Baracos et al., Cancer-associated cachexia, Nature Reviews, 2018 
 
   [2] Argilés et al. Cancer cachexia: understanding the molecular 
basis. Nat Rev Cancer 2014 
 
 
 
 
 
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February 08, 2021 01:00 ET (06:00 GMT)