该项重要的决定基于阿斯利康AEGEAN 3期临床试验的数据，该试验数据表明，与手术前后的单纯化疗效果相比较而言，Imfinzi作为联合治疗手段可将复发、进展或死亡的风险大幅降低32%。AstraZeneca announced on Friday that the US Food and Drug Administration (FDA) has approved its blockbuster anti-PD-L1 immunotherapy imfinzi (durvalumab) for another lung cancer indication.
The Zhitong Finance App learned that British pharmaceutical giant AstraZeneca (AZN.US) announced on Friday that the US Food and Drug Administration (FDA) has approved its major drug, the anti-PD-L1 immunotherapy drug imfinzi (durvalumab), for another lung cancer indication. AstraZeneca added that the latest approval allows Imfinzi to be used along with traditional chemotherapy in certain resectable early non-small cell lung cancer (NSCLC) treatment options before and after surgery for adult patients with resectable early non-small cell lung cancer (NSCLC).
Specifically, in the absence of a specific oncogene sequence (i.e., epidermal growth factor receptor mutation or anaplastic lymphoma kinase rearrangement), monoclonal antibodies against PD-L1 can be used as an aid to chemotherapy in patients with non-small cell lung cancer.
The important decision was based on data from AstraZeneca's AEGEAN phase 3 clinical trial, which showed that compared to the effects of simple chemotherapy before and after surgery, Imfinzi as a combination treatment could significantly reduce the risk of recurrence, progression, or death by 32%.
Imfinzi was first approved in 2017 as a combination therapy for the treatment of metastatic NSCLC in the US market.
The mechanism of action of AstraZeneca Imfinzi gives Imfinzi an advantage over traditional chemotherapy in treating certain types of cancer. Imfinzi is an immune checkpoint inhibitor that targets PD-L1 protein. This targeted treatment can more accurately inhibit the immune escape mechanism of tumor cells without causing extensive damage to rapidly dividing cells (including healthy cells) throughout the body like chemotherapy.
Chemotherapy works by killing rapidly dividing cells, but this mechanism also affects healthy cells, leading to various side effects such as hair loss, fatigue, and increased risk of infection. In contrast, Imfinzi's immunotherapy is more targeted, and multiple AstraZeneca trials have shown very few side effects, and in combination with moderate chemotherapy, it can improve the healing effect of cancer.