AstraZeneca and Daiichi Sankyo receives partial approval in China
AstraZeneca and Daiichi Sankyo have announced that the duo’s antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), has received conditional approval from the China National Medical Products Administration (NMPA) for gastric cancer. Now, Enhertu can be used as a single agent for adults with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, as long as they have undergone at least two previous treatments.
The positive outcomes of the DESTINY-Gastric06 Phase II trial were a key influencing factor behind the NMPA’s decision. The trial was a single-arm study focusing on the safety and efficacy of Chinese patients who had been treated for HER2-positive gastric or GEJ adenocarcinoma previously. Additional approval came in the form of evidence from the DESTINY-Gastric01 Phase II trial involving patients from Japan and South Korea.
45 countries and regions have already sanctioned the use of Enhertu for advanced or metastatic gastric cancer. The therapy treatment was given the seal of approval from the FDA in April. However, AstraZeneca and Daiichi Sankyo must wait for the results of a randomised controlled confirmatory trial before receiving full approval in China.
Dave Fredrickson, Executive Vice-President of the Oncology Business Unit at AstraZeneca, 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.”