Review the approved treatment of non-small cell lung cancer in 2022 (FDA&NMPA) ——Small Molecule Inhibitor

On March 21, 2022, Betta Pharmaceuticals Co., Ltd. received the "Drug Registration Certificate" issued by the State Drug Administration

NMPA Approval

March 21, 2022 Ensartinib (first-line treatment for lung cancer)

On March 21, 2022, Betta Pharmaceuticals Co., Ltd. received the "Drug Registration Certificate" issued by the State Drug Administration (drug approval number: GUO XIE ZHU ZHUN H20200009, GUO YAO ZHUN ZI H20200010), Ensartinib. hydrochloride capsule has been approved for marketing as a new indication for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) (referred to as "first-line treatment indication"), which is the second indication approved by Ensartinib. The above approval is based on the eXalt 3 multicenter clinical study. The eXalt 3 study is a global open multicenter randomized controlled phase III clinical study designed to evaluate the effect and safety treatment of Ensartinib versus Crizotinib on untreated (first-line) patients with ALK. positive in NSCLC patients. In the eXalt 3 global multi-center clinical study, the 4-year OS rate of Ensartinib in the baseline population without brain metastases reached 75.7%; the 4-year OS rate in the baseline population with brain metastases reached 47.7%; the 4-year OS rate in the overall population reached 66.3% %. [1]

March 24, 2022, Dabrafenib combined with Trametinib (full line treatment for lung cancer)

On March 25, 2022, the Novartis Group WeChat Page announced that Novartis (China) dual-targeted combination therapy drug Tafinlar® Dabrafenib mesylate Capsules and Mekinist® indication for the treatment of BRAF V600 mutation-positive metastatic non-small cell lung cancer. The approval of the indications in China is based on the registered clinical study on the treatment of BRAF mutation-positive metastatic NSCLC in the Chinese population with Dabrafenib combined with Trametinib. This study is a national multicenter phase II clinical trial led by Professor Zhang Li from the Cancer Prevention and Treatment Center of Sun Sun Yat-sen University. The study confirmed that Dabrafenib combined with Trametinib has excellent efficacy in treating metastatic NSCLC with BRAF V600E mutation. [2]

March 24, 2022 Brigatinib (first line treatment lung cancer)

On March 24, 2022, the ALK inhibitor Brigatinib of Takeda Pharmaceutical was approved by NMPA for marketing, which is applicable to the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with anaplastic lymphoma kinase (ALK) positive. Alunbrig® (Brigatinib) was approved based on the research data of the global phase clinical trial ALTA-1L. The results of the study confirmed that the acceptance of Alunbrig® The median PFS of patients treated with (Brigatinib Tablets) reached 24 months after evaluation by the independent review committee, while the median PFS of the control group was 11.1 months (HR=0.48, P<0.0001), and the median PFS of the researchers reached 30.8 months compared with 9.2 months in the control group (HR=0.43, P<0.0001), which reduced the risk of disease progression or death by 57% compared with the control group. In addition, it has a breakthrough effect on patients with baseline brain metastasis: the median PFS reached 24 months after evaluation by the independent review committee, and 5.6 months in the control group (HR=0.25, P<0.0001), significantly reducing the risk of disease progression or death by 75% compared with the control group. Alunbrig®The 4-year OS rate of patients with brain metastasis at the baseline of first-line treatment was 71%, and the risk of death was reduced by 57% (the 4-year OS rate of the control group was 44%, HR=0.43, P=0.02). [3]