Trastuzumab Deruxtecan Type II Variation Application Validated by EMA
Release time：2021-11-15 10:02:00
Trastuzumab Deruxtecan Type II Variation Application Validated by EMA for the Treatment of HER2 Positive Advanced Gastric Cancer
TOKYO & MUNICH--(BUSINESS WIRE)--Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the European Medicines Agency (EMA) has validated the Type II Variation Application for trastuzumab deruxtecan, a HER2 directed antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN), for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior anti-HER2-based regimen.
Validation confirms that the application is complete and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). This application is based on the positive results from the DESTINY-Gastric01 pivotal phase 2 trial published in The New England Journal of Medicine and the DESTINY-Gastric02 phase 2 trial recently presented at the 2021 European Society for Medical Oncology (ESMO) Congress.
“After progression on initial therapy, patients with HER2 positive advanced gastric cancer are faced with limited options in Europe, so there is a significant unmet need for new therapeutic options,” said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. “We look forward to working with the EMA on its review of this application and to potentially bring trastuzumab deruxtecan to physicians and patients in Europe, as it offers the potential to provide an important new treatment option to patients with locally advanced or metastatic HER2 positive gastric or GEJ adenocarcinoma who have received a prior anti-HER2-based regimen.”