Phacilitate Leaders Forum

15th – 16th October 2019

Kerry Hotel Pudong, Shanghai

First Anti-PD-1 drug approved by CFDA in China

First Anti-PD-1 drug approved by CFDA in China

Recently, the State Drug Administration of China approved the application for the import registration of NMV (Nivolumab) Injection, used for the treatment of adult patients with a negative gene mutation of epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who were previously treated with accepted platinum regimens for disease progression or intolerance.

 

At present, the research hot spots in the field of tumor immunotherapy mainly focus on immunosuppressive agents such as anti-programmed death-1 (PD-1) receptor, which is different from traditional chemotherapy and targeted therapy as it targets immunosuppression in the patient's body and works to reactivate his or her own immune cells to kill the tumor. This represents a completely new approach to antitumor treatment. The approved NMV Injection is a human monoclonal antibody to the PD-1 receptor, developed by Bristol-Myers Squibb. It acts by blocking the PD-1 of the T lymphocyte preventing it from binding to the PD-L1 on the surface of the tumor cells and thus relieving the immunosuppression of the immune cells by the tumor cells. The immune cells can then replay the role of antitumor immunization, thus killing the tumor cells.

 

Bristol-Myers Squibb first launched and completed clinical trials of the drug in China in patients with advanced non-small cell lung cancer who had experienced progression of the disease after the platinum double-drug chemotherapy. On the basis of the clinical trial results they submitted the application for imported drug registration accordingly. The State Drug Administration of China, in accordance with the priority review procedure, sped up the technical review and completed the field verification of its clinical trial data and approved the import registration on June 15, 2018.

 

Lung cancer is a malignant tumor with a very high incidence globally. In recent years, some targeted drugs have produced relatively good results in the field of lung cancer treatment. However, chemotherapy is still the main treatment for advanced non-small cell lung cancer with non-driven gene mutation, and the total survival time is usually rather short. The clinical trial data of this drug has served to show that, compared with the existing second-line standard treatment, the overall median survival period of patients with advanced non-small cell lung cancer could be prolonged for 3 months.

 

The NMV Injection is the first monoclonal antibody drug targeted at PD-1 in China and marks a significant step in making advanced therapy clinical medications more available for cancer patients in the country.