AstraZeneca’s Enhertu has scored a priority review from the US Food and Drug Administration (FDA) for the treatment of HER2-positive metastatic gastric cancer.
Daiichi Sankyo-partnered Enhertu (trastuzumab deruxtecan) has received acceptance for its supplemental biologics licence application (sBLA) from the FDA, in addition to the priority review, for the treatment of HER2-positive metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
According to AZ, the FDA action date for their regulatory decision for Enhertu in this indication has been set during the first quarter of 2021.
The sBLa was based on results from the DESTINY-Gastric01, which demonstrated a statistically significant and clinically meaningful improvement in objective response rate (ORR) – the primary endpoint – and overall survival, a key secondary endpoint.
“Once patients with HER2-positive metastatic gastric cancer progress following initial treatment with an anti-HER2 regimen, there are no approved HER2-directed medicines,” said José Baselga, executive vice president, oncology R&D, AZ.
“The prognosis for these patients is poor, as available treatment options offer only limited clinical benefit.
“This milestone brings us one step closer to delivering a potentially practice-changing medicine to patients with gastric cancer in the US,” he added.
Previously, Enhertu received a breakthrough therapy designation in May 2020 for patients with unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma who have received two or more prior regimens.