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FDA has granted priority review for the companies’ sBLA for Enhertu, an ADC for treating gastric cancers.
AstraZeneca and Daiichi Sankyo announced on Oct. 28, 2020 that their supplemental biologics license application (sBLA) for Enhertu (trastuzumab deruxtecan), an antibody drug conjugate (ADC) for treating HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma, was accepted by FDA and granted priority review.
FDA’s acceptance of the sBLA was based on positive results from a Phase II trial (Destiny-Gastric01), which showed improvement in objective response rate, the primary endpoint, and overall survival in patients treated with the therapeutic, according to an AstraZeneca press release.
“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, AstraZeneca, in the press release. “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 [United States].”
“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,” added Antoine Yver, executive vice-president and global head, Oncology R&D, Daiichi Sankyo, in the press release. “Building on the recent [b]reakthrough [t]herapy [d]esignation, the filing of the application, and [p]riority [r]eview by [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.”