(Sharecast News) – AstraZeneca and its partner Daiichi Sankyo announced on Monday that ‘Enhertu’, or trastuzumab deruxtecan. has been approved in the United States for the treatment of advanced gastric cancer.
The FTSE 100 pharmaceuticals giant said that specifically, the approval was for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction
Adenocarcinoma, who had received a prior trastuzumab-based regimen.
It said that in the US, gastric cancer was most frequently diagnosed in the advanced stage, with only about 5% of patients surviving beyond five years.
Approximately one in five gastric cancers are HER2-positive.
The company said the approval by the US Food and Drug Administration (FDA) was based on positive results from the randomised ‘DESTINY-Gastric01’ phase 2 trial conducted in Japan and South Korea.
In the trial, Enhertu demonstrated a statistically significant and clinically meaningful improvement in overall survival and objective response rate over chemotherapy, being irinotecan or paclitaxel, in patients with advanced gastric cancer or GEJ adenocarcinoma, who had progressed on at least two or more prior regimens including trastuzumab plus a fluoropyrimidine- and platinum-based chemotherapy combination.
“Today’s approval of Enhertu represents the first HER2-directed medicine approved in a decade for patients with HER2-positive metastatic gastric cancer,” said Dave Fredrickson, executive vice-president of AstraZeneca’s oncology business unit.
“The results from the DESTINY-Gastric01 trial highlight the potential to change clinical practice, showing a 41% improvement in survival and a response rate more than three times higher with Enhertu compared to chemotherapy.
“We are thrilled to bring this important medicine to more patients and physicians in the US.”
At 0812 GMT, shares in AstraZeneca were up 0.36% at 7,619p.
