Daiichi Sankyo and AstraZeneca’s Enhertu obtain NMPA approval for HER2 GEJ
Enhertu (trastuzumab deruxtecan) from Daiichi Sankyo and AstraZeneca has acquired approval from China’s Nationwide Medical Merchandise Administration (NMPA) for adults with regionally superior or metastatic human epidermal progress issue receptor 2 (HER2) constructive gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The approval applies to sufferers who’ve beforehand acquired trastuzumab-based therapy.
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Extra data
Enhertu is a purpose-built HER2-targeted DXd-antibody drug conjugate found by Daiichi Sankyo and co-developed with AstraZeneca.
The approval is supported by information from the DESTINY-Gastric04 Part III trial.
The China Middle for Drug Analysis beforehand granted Enhertu breakthrough remedy standing for this indication. The remedy has additionally been granted precedence evaluate standing, permitting for accelerated approval.
In DESTINY-Gastric04, Enhertu demonstrated a 30% discount within the danger of dying towards ramucirumab plus paclitaxel for second-line HER2-positive unresectable or metastatic gastric or GEJ adenocarcinoma. Median total survival was 14.7 months with Enhertu versus 11.4 months for the comparability group.
Development-free survival evaluation indicated a 26% decrease danger of illness development or dying with Enhertu. The confirmed goal response fee was 44.3% for Enhertu, with seven full responses and 97 partial responses.
Michio Hayashi, President of Daiichi Sankyo China, stated: “This sixth approval for Enhertu in China in lower than three years totally demonstrates the potential of this modern drug to make necessary contributions to medical apply.
“DESTINY-Gastric04 is the primary ever randomized Part III trial to show a survival profit within the second-line HER2-positive metastatic gastric most cancers setting and in addition confirms the outcomes of the DESTINY-Gastric01 and DESTINY-Gastric06 trials.”
Enhertu can be being evaluated within the DESTINY-Gastric05 and ARTEMIDE-Gastric01 Part III trials as a possible first-line therapy choice for HER2-positive metastatic gastric most cancers.
In September 2025, Daiichi Sankyo and AstraZeneca acquired a precedence evaluate from the US Meals and Drug Administration (FDA) for Enhertu’s supplemental biologics advertising authorization utility (sBLA) together with pertuzumab.
