FDA grants ENHERTU breakthrough therapy for HER2-positive antibody drug conjugated to treat HER2-positive metastatic stomach cancer

First Sando co-op and Aslicon's targeted HER2 antibody drug conjugated enHERTU (FAM-trastuzumab deruxtecan-nxki) were awarded the FDA-awarded breakthrough therapy (BTD) for the treatment of patients who have received two or more treatment options (including quertop) positive, non-reprecentable or metastatic stomach or gastric tube junction adenocarcinomastomach cancer is the third leading cause of cancer death, with a five-year survival rate of 5% for metastatic gastric cancer and about one-fifth of gastric cancers being tested positive for HER2, Executive Vice President of Research and Development of AstraZeneca Oncology, said: 'For HER2-positive metastatic gastric cancer patients, the current treatment options are very limited and there is no approved HER2 target drug for those who are progressingWe look forward to working with the FDA to further explore enHERTU's potential to become a new treatment for this important disease and the first antibody drug conjugateTheFDA approval of BTD is based on key Phase 2 DESTINY-Gastric01 trial data and Phase 1 trial dataTHE RESULTS OF THE DESTINY-GASTRIC01 STUDY SHOWED A STATISTICALLY SIGNIFICANT AND CLINICAL IMPROVEMENT IN THE OBJECTIVE RESPONSE RATE (ORR) AND OVERALL SURVIVAL RATE (OS) AFTER ENHERTU TREATMENT IN PATIENTS WITH HER2-POSITIVE METASTATIC GASTRIC CANCER WHO HAD PROGRESSED AFTER TWO TREATMENTS COMPARED TO THOSE WHO RECEIVED CHEMOTHERAPY (ILITOCON OR YEWALCOHOL MONOTHERAPY)ENHERTU has recently received accelerated approval from the United States and japan for the treatment of adult patients who have received two or more treatments based on antiHER2, HER2-positive, non-recative or metastatic breast cancer