When was Tarlatamab-Imdelltra launched in the country?

Tarlatamab-Imdelltra is an innovative immuno-oncology drug developed by Amgen. Through a bispecific T cell connection mechanism, it can redirect T cells to tumor cells expressing DLL3, thereby exerting a targeted killing effect. This drug is particularly suitable for malignant tumors such as small cell lung cancer (ES-SCLC) with limited treatment options and high recurrence rates. Therefore, it has attracted great attention from the international medical community since its early development.

In May 2024, the U.S. Food and Drug Administration (FDA) officially approved Imdelltra's marketing application for the treatment of relapsed or refractory small cell lung cancer. This approval is based on data support from multiple clinical trials, showing that Tarlatamab has positive significance in delaying disease progression and improving survival outcomes in some patients. It is worth noting that as the first DLL3-targeted immunotherapy drug approved by the FDA, the launch of Imdelltra is considered an important breakthrough in the field of small cell lung cancer.

However, as far as the Chinese market is concerned, Tarlatamab has not yet been approved for marketing. Since the drug has just been approved overseas, the domestic registration application and review process is still in the advanced stage. Normally, it may take 1 to 3 years from FDA approval to China National Medical Products Administration (NMPA) acceptance to official marketing, depending on the completeness of clinical data submission and whether there is a policy channel for priority review. In other words, Chinese patients will not be able to directly obtain Imdelltra through formal channels in the short term. However, in the future, with the deepening of global clinical research and the attention of multinational pharmaceutical companies to the Chinese market, talatumumab is expected to accelerate its entry into the country.

Currently, if Chinese patients want to use the drug, the main way is to obtain it through international medical channels or the Global Drug Early Access Project (EAP), but the price is higher, and the risks and benefits need to be carefully evaluated under the guidance of a doctor.

Reference materials:https://www.drugs.com/mtm/tarlatamab.html