FDA Grants Breakthrough Therapy Designation for HER2-positive Metastatic Gastric Cancer Treatment

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to trastuzumab deruxtecan (Enhertu; AstraZeneca, Daiichi Sankyo) for the treatment of patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab.

“Current therapy options are limited for patients with HER2-positive metastatic gastric cancer and for those who relapse, there are no approved HER2-targeted medicines,” said José Baselga, Executive Vice President, R&D Oncology, in a company press release. “We look forward to working with the FDA to further explore the potential of Enhertu to become an important new treatment and the first antibody drug conjugate for this devastating disease.”

Read the full press release here.