HER2 Directed Medicine Approved for Gastric Cancer Patients
Daiichi Sankyo and AstraZeneca announced that on January 15, 2021, ENHERTU® had been approved in the U.S. to treat adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
Regular approval by the U.S. FDA was based on the positive results from the randomized pivotal DESTINY-Gastric01 phase 2 trial, in which ENHERTU demonstrated a statistically significant and clinically meaningful improvement in overall survival and objective response rate versus chemotherapy (irinotecan or paclitaxel) in patients with advanced gastric or GEJ adenocarcinoma who had progressed on at least two prior regimens including trastuzumab, a fluoropyrimidine, and platinum-containing chemotherapy.
ENHERTU is approved with Boxed WARNINGS for interstitial lung disease (ILD)/pneumonitis and embryo-fetal toxicity.
Ronan Kelly, M.D., MBA, Director of the Charles A. Sammons Cancer Center and the W.W. Caruth, Jr. Chair of Immunology at Baylor University Medical Center, Dallas, Texas, said in a press statement, “This approval represents the first time a HER2 directed medicine has demonstrated a significant improvement in survival compared to chemotherapy for patients following initial treatment in the metastatic setting, and it has the potential to become the new standard of care for this patient population.”
Approximately one in five gastric cancers are HER2 positive.