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Enhertu US orphan designation in gastric cancer
Enhertu US orphan designation in gastric cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n RNS Number : 7385N\n AstraZeneca PLC\n 22 May 2020\n \n \n \n 22 May 2020 07:00 BST\n \n \n \n Enhertu \n \n \n granted \n \n \n Orphan Drug Designation in the US \n \n \n for\n \n \n gastric cancer\n \n \n \n \n \n \n Designation follows recent US Breakthrough Therapy Designations for Enhertu for HER2-positive metastatic gastric cancer and HER2-mutant metastatic non-small cell lung cancer\n \n \n AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)'s Enhertu (trastuzumab deruxtecan) has been granted Orphan Drug Designation (ODD) in the US for the treatment of patients with gastric cancer, including gastroesophageal junction cancer.\n \n \n \n An estimated 27,600 new cases of gastric cancer will be diagnosed this year and the disease could lead to more than 11,000 deaths in the US in 2020.1\n \n \n \n \n The Food and Drug Administration (FDA) grants ODD to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.\n \n \n \n \n In the Phase II DESTINY-Gastric01 trial, patients with HER2-positive metastatic gastric or gastroesophageal cancer who were treated with Enhertu, a HER2-directed antibody drug conjugate (ADC), demonstrated a statistically significant and clinically meaningful improvement in objective response rate (ORR), the primary endpoint, and overall survival (OS), a key secondary endpoint, versus patients treated with investigator's choice of chemotherapy (irinotecan or paclitaxel monotherapy).\n \n \n The overall safety and tolerability profile of Enhertu (6.4mg/kg) in DESTINY-Gastric01 was consistent with that seen in the Phase I gastric cancer trial. The most common adverse events were haematologic and gastrointestinal including neutrophil count decrease, anaemia, nausea and decreased appetite. There were cases of drug-related interstitial lung disease (ILD) and pneumonitis, the majority of which were Grade 1 and 2, with two Grade 3 and one Grade 4. No Grade 5 events (ILD-related deaths) occurred in patients with gastric cancer in the Phase I trial or in the Phase II DESTINY-Gastric01 trial.\n \n \n \n \n \n The full results of DESTINY-Gastric-01 will be presented during the \n 2020 American Society of Clinical Oncology ASCO20 Virtual Scientific Program, 29 to...