Fam-trastuzumab gets BTD for metastatic gastric cancer

June 10, 2020 0 By FM

Fam-trastuzumab deruxtecan-nxki (Enhertu) has been granted Breakthrough Therapy Designation (BTD) in the US 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. 

Approximately one in five gastric cancers are considered HER2 positive.

The US FDA granted the BTD based on data from the pivotal phase 2DESTINY-Gastric01 trial.

In the trial, patients with HER2 positive metastatic gastric cancer who progressed after two previous regimens treated with fam-trastuzumab, a HER2 directed antibody drug conjugate (ADC), demonstrated a statistically significant and clinically meaningful improvement in objective response rate (ORR) and overall survival (OS) compared to patients treated with investigator’s choice of chemotherapy (irinotecan or paclitaxel monotherapy).