Has zolbetuximab been officially launched and when will it be launched?

Zoltuximab (zolbetuximab) is a new type of targeted drug, mainly used to treat digestive system tumors such as gastric cancer and gastroesophageal junction (GEJ) adenocarcinoma. It works by targeting the Clark factor receptor (CLDN18.2) on the surface of cancer cells, helping to inhibit the proliferation and spread of cancer cells. The drug's availability and approval status varies by country and region and is expected to provide new treatment options globally.

In Japan, zotuximab is expected to be officially launched in March 2024. Japan's approval schedule is in sync with other countries, and the drug is expected to play an important role in the treatment of gastric cancer. The targeting effect of zotuximab enables it to provide more precise treatment and reduce unnecessary side effects when treating patients who are positive for specific cancer cell surface markers (such as CLDN18.2). In the EU, zotuximab was approved in September 2024 and officially launched on the market. The European approval also brings new hope for the treatment of gastric cancer and other digestive system tumors. Unlike other traditional treatment methods, zotuximab can target specific receptors on cancer cells and precisely intervene in the proliferation mechanism of cancer cells, thereby improving the therapeutic effect and reducing unnecessary side effects of treatment.

In the United States, zotuximab will be approved in October 2024, and the U.S. Food and Drug Administration (FDA) has recognized the drug as a first-class treatment option. FDA approved zotuximab in combination with fluoropyrimidine- and platinum-containing chemotherapy for the treatment of locally advanced unresectable or metastatic HER2 negative gastric cancer or gastroesophageal junction adenocarcinoma.

In addition, zotuximab was approved and launched in China in December 2024. With the gradual rollout of the drug globally, it is expected that gastric cancer patients in China will also benefit from this new type of targeted therapy. China's approval will provide new treatment options for more patients with gastric cancer and gastroesophageal junction adenocarcinoma, especially in the field of precision treatment targeting specific tumor markers.

References: https://www.astellas.com/en/news/29401