Hengrui medicine announced on October 23, said: recently, Hengrui medicine innovative drug pearl single line treatment of tumor cells PD-L1 expression positive [tumor proportion score (TPS) 1%] and not accompanied by EGFR / ALK gene abnormal recurrent or metastatic non-small cell lung cancer by the national drug administration drug review center for the breakthrough treatment varieties of public list.
According to the GLOBOCAN 2020 report, lung cancer has the second highest incidence of all malignancies, but the mortality rate is the first, seriously threatening people's healthy [1]. Of all pathologic histological types of lung cancer, NSCLC accounts for approximately 85% of [2]. Due to the lack of early obvious symptoms, most NSCLC have advanced metastatic lung cancer when diagnosed, with a poor overall prognosis. In the past decade, the treatment of advanced NSCLC has gradually changed from chemotherapy therapy to individualized therapy based on driver gene mutation: driver gene mutations can benefit significantly better from targeted therapy, and targeted immune-checkpoint inhibitors like PD-1 / PD-L1, prolonging the survival of advanced NSCLC. However, currently, first-line monotherapy for locally advanced or metastatic NSCLC with 1% of the EGFR gene mutation negative and ALK negative for PD-L1 TPS still has a relatively limited clinical benefit of [3]. Therefore, on the basis of the effective current immunotherapy, how to further improve the efficacy of immunotherapy, expand the population benefiting from immunotherapy, and realize the vision of dechemotherapy for driver gene-negative NSCLC are important unmet clinical needs.
Carreilizumab for injection is a humanized PD-1 monoclonal antibody independently developed by Hengrui Pharmaceutical and with intellectual property rights. It can bind to the human PD-1 receptor and block the PD-1 / PD-L1 pathway, and restore the body's anti-tumor immunity, thus forming the basis of cancer immunotherapy. Since its launch in May 2019, it has been approved in the five major tumors of lung cancer, liver cancer, esophageal cancer, nasopharyngeal cancer and lymphoma successively, of which 2 are the first-line treatment of NSCLC, and it is one of the leading domestic PD-1 products with the approved indications and the number of covered tumors. Famitinib malate capsule is a small molecule multi-target tyrosine kinase inhibitor independently developed by Hengrui. It has inhibitory activity on a variety of receptor tyrosine kinases and belongs to a multi-target anti-angiogenic targeting drug.
At present, Hengrui Pharmaceutical is conducting a randomized, open-label, controlled, multi-center phase clinical study of carizumab combined with famitinib malate compared with aborolizumab in first-line treatment of recurrent or metastatic non-small cell lung cancer with positive PD-L1 lung cancer.
What is a breakthrough therapy determination?
In order to encourage research and development of drugs with obvious clinical advantages, the Drug Evaluation Center (CDE) issued the State Food and Drug Administration on
