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MacroGenics Announces Margetuximab Granted Orphan Drug Designation in the U.S. for Gastric Cancer
Rockville, MD, June 05, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and
About this update from Macrogenics, Inc.
[{"type":"text","content":"Rockville, MD, June 05, 2020 (GLOBE NEWSWIRE) -- \n MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to margetuximab, an investigational, Fc-engineered monoclonal antibody targeting HER2 for the treatment of gastric and gastroesophageal junction cancer. Margetuximab is currently being evaluated in the Phase 2/3 MAHOGANY clinical trial in combination with checkpoint inhibition, with or without chemotherapy, as a potential first-line treatment for patients with HER2-positive gastric cancer (GC) or gastroesophageal junction (GEJ) cancer. The MAHOGANY study is based on results from an ongoing Phase 2 study of margetuximab plus pembrolizumab, an anti-PD-1 monoclonal antibody, for patients with advanced HER2-positive GC or GEJ cancer who have previously been treated with chemotherapy and trastuzumab in the metastatic setting. Data were presented at the European Society for Medical Oncology (ESMO) Annual Congress in September 2019. “We are pleased that the FDA has granted orphan status to margetuximab,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “We believe that our immune-enhancing antibody targeting HER2 has the potential to improve upon the clinical activity of existing standard of care for patients with gastric or gastroesophageal cancer.” The FDA grants ODD to medicines intended for the treatment, diagnosis or prevention of rare diseases of disorders that affect fewer than 200,000 people in the U.S. The designation provides certain incentives, which may include seven years of marketing exclusivity for the orphan indication, certain federal grants, tax credits and waiver of certain FDA fees. About Gastric and Gastroesophageal Junction Cancer Cancer of the stomach (gastric cancer) or the gastroesophageal junction (where the esophagus joins the stomach) is collectively known as gastroesophageal adenocarcinoma. According to the American Cancer Society, approximately 27,600 new cases of gastric cancer will be diagnosed in the U.S in 2020 and more than 11,000 people will die from the disease. Both GC and GEJ cancer are often diagnosed at an advanced stage and therefo...