AstraZeneca and Daiichi Sankyo have secured China’s National Medical Products Administration (NMPA) conditional approval for Enhertu (trastuzumab deruxtecan) to treat a type of gastric cancer.
Enhertu is an antibody-drug conjugate (ADC) specifically engineered to target human epidermal growth factor receptor 2 (HER2), using Daiichi Sankyo’s in-house DXd ADC technology.
The drug is indicated for adult patients who have previously been treated for locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.
NMPA’s conditional approval can be converted into full approval for this indication, based on the drug achieving clinical benefit in a confirmatory clinical trial.
Daiichi Sankyo Asia, South and Central America Business Unit head Kiminori Nagao said: “This milestone marks the third approval in China for Enhertu in less than two years, following approvals for HER2-positive metastatic breast cancer and HER2-low metastatic breast cancer.
“Our DESTINY clinical trial programme continues to reinforce Enhertu as a practice-changing treatment option for patients with HER2-expressing cancers and this latest approval in China further illustrates the global impact of this innovative antibody drug conjugate.”
NMPA’s conditional approval was based on the results from the Phase 2 DESTINY-Gastric06 clinical trial, in which Enhertu showed clinically meaningful efficacy in participants from China.
In the Phase 2 study, Enhertu showed a safety profile that was consistent with previous clinical trials of Enhertu in gastric cancer with no new safety concerns identified.
The conditional approval was also supported by results from the Phase 2 DESTINY-Gastric01 trial, which included patients from Japan and South Korea.
In the clinical trial, treatment of patients with HER2-positive gastric cancer with Enhertu showed a statistically significant improvement in confirmed ORR and median overall survival (OS).
Enhertu is already approved in more than 45 countries, including the US, Japan, and several countries in the EU, to treat advanced or metastatic gastric cancer and other cancers.
AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “China accounts for more than a third of patients with gastric cancer globally and most patients are diagnosed with advanced disease.
“This approval of Enhertu brings a much-needed, new targeted treatment option to patients with HER2-positive metastatic gastric cancer in China and underscores our commitment to bringing this innovative medicine to more patients across the globe living with HER2-expressing cancers.”
