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Daiichi Sankyo, AstraZeneca's sBLA for Enhertu in Gastric Cancer Accepted by FDA

NEW YORK – Daiichi Sankyo and AstraZeneca announced on Tuesday that the US Food and Drug Administration has accepted the supplemental biologics license application for trastuzumab deruxtecan (Enhertu) to treat patients with HER2-positive gastric cancer.

The FDA also granted priority review for trastuzumab deruxtecan for the treatment of patients with HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma. The treatment also has received a breakthrough therapy designation and orphan drug designation for this indication.

The FDA's decision was based on data from the DESTINY-Gastric01 Phase II clinical trial, presented earlier this year at American Society of Clinical Oncology meeting. That trial showed significant improvement in overall response rate for patients taking trastuzumab deruxtecan compared to chemotherapy. The FDA set the PDUFA date for first quarter 2021.

"The results of the DESTINY-Gastric01 trial are unprecedented as they represent the first time a HER2 directed medicine has demonstrated an improvement in survival following chemotherapy and HER2 treatment in the metastatic setting,” Antoine Yver, global head of oncology research and development at Daiichi Sankyo, said in a statement. “Building on the recent breakthrough therapy designation, the filing of the application and priority review by the FDA for this potential new indication for Enhertu reflects the importance of the data and the significant unmet need for patients with previously treated HER2-positive metastatic gastric cancer.”

Trastuzumab deruxtecan was recently approved in Japan for treatment of HER2-positive unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy. The drug is also approved in the US and Japan to treat HER2-positive breast cancer.