Roche Pharmaceuticals China announced today that China’s National Medical Products Administration (NMPA) has officially approved Roche’s targeted anti-cancer drug Luo Shengquan (English trade name: ROZLYTREK, Chinese and British generic name: Entrectinib/Entrectinib ) is used to treat adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (hereinafter referred to as NSCLC).
This is the second indication approved by Luo Shengquan in China in less than two weeks after it was approved on July 29 for the treatment of patients with NTRK fusion gene-positive solid tumors.
As of the date of approval, entrectinib is the first ROS1 inhibitor approved in China with clear central nervous system (Central Nervous System, hereinafter referred to as CNS) efficacy. It is expected to fill the treatment gap in the field of specific lung cancer and is the first ROS1-positive NSCLC in China. It gives patients new hope for long-term survival.
Chinese ROS1-positive lung cancer patients have huge unmet clinical needs
According to the national cancer statistics released by the National Cancer Center in 2022, China ranks first in the national incidence and mortality rate of lung cancer. In 2016 alone, more than 828,000 people were diagnosed with lung cancer, of which non-small cell lung cancer (NSCLC) accounted for approximately 85% of all lung cancers.
ROS1 is a coding receptor tyrosine kinase, which is structurally similar to anaplastic lymphoma kinase (ALK). It is a rare driver gene clearly identified in NSCLC. The incidence rate in the Chinese population is between 1-3%, and the fusion ( Rearrangement) is the main mutation type of ROS1 gene. The proportion of patients with ROS1 fusion-positive NSCLC who develop central nervous system (CNS) metastasis when the disease is diagnosed is as high as 40%.
Entrectinib is a potent and selective inhibitor targeting pan-TRK and ROS1 tyrosine kinases. It has central nervous system (CNS) activity and can cross the blood-brain barrier by blocking ROS1 and NTRK kinases. activity, causing the death of ROS1-positive or NTRK-positive cancer cells.
A new generation of targeted precision therapy lights up a new dawn for ROS1-positive patients
The National Medical Products Administration (NMPA) approved entrectinib for the treatment of ROS1-positive NSCLC patients this time, mainly based on three phase I/II clinical studies ( Combined analysis results of ALKA-372-001, STARTRK-1, STARTRK-2). The results showed that entrectinib data showed efficacy regardless of the presence or absence of central nervous system (CNS) metastases.
Based on the data update from the 2022 World Conference on Lung Cancer (WCLC), in the first-line treatment of patients with ROS1-positive NSCLC, the overall objective response rate (ORR) of entrectinib reached 68.7%, and the median duration of response (DOR) reached 35.6 months month, the median progression-free survival (PFS) was 17.7 months, and the median overall survival (OS) was 47.7 months. At the same time, entrectinib has demonstrated excellent brain protection effects: the risk of intracranial metastasis in patients treated with entrectinib for 12 months is only 1%; and patients with measurable brain metastases at baseline have an intracranial objective response rate (IC-ORR) also reached 80.0%, showing intracranial anti-tumor effect, and the drug is safe and tolerable.
In recent years, great progress has been made in the treatment of rare gene mutations, which not only brings tangible benefits to patients, but also promotes the long-term development of rare target treatment options. As the chief investigator of STARTRK-2, the global clinical study of entrectinib, Professor Lu Shun of Shanghai Jiao Tong University Affiliated Chest Hospital said : “At present, the domestic ROS1 targeted treatment options are relatively limited, and there are still many unidentified clinical options. Meet the needs of a new generation of RO. The approval of the S1 inhibitor entrectinib brings new treatment options to Chinese patients with ROS1-positive NSCLC.”
As my country’s clinical research level continues to improve, Chinese clinical trials are gradually in line with international standards, and more innovative drugs are accelerating in China. It is launched on the market and brings innovative treatment solutions to Chinese patients that are in sync with the world. Regarding the approval of entrectinib in China, Professor Fan Yun from the Cancer Hospital of the University of Chinese Academy of Sciences said : "Enrectinib has shown therapeutic benefits consistent with those of the global population in the Chinese population. It is ROS1 positive in China. It provides patients with more treatment options and drug accessibility. It is hoped that such innovative drugs can quickly enter China in the future and add another weapon to the clinical fight against cancer."
benefits Chinese patients and helps healthy China 2030
in August 2019. The US FDA approves Ensteinib for treating ROS1 positive non -small cell lung cancer (NSCLC). Sexual target ROS1 and NTRK At present, the latest guidelines at home and abroad have been entered into the recommendation plan. NSCLC一线首选治疗方案。
罗氏全球药品开发中国中心负责人李昕表示：“恩曲替尼获批用于治疗ROS1阳性非小细胞肺癌患者，将为中国ROS1阳性非小细胞肺癌患者带来A longer hope of survival. In the future, Roche will continue to invest in research and development in the field of lung cancer, and strive to continue to break through in the field of rare targets for lung cancer, which will benefit more patients with lung cancer. "
Roche Pharmaceutical Chinese President Bian Xin said: " In just two weeks, after the NTRK indications were approved, the Ros1 indications were approved by the Chinese government, and the non -ROS1 positive non -non -non -non -non -non -non -non -non -non -non -non -non -non -non -non -non -non -non -non -non -non -non -non -non -non -non -non -non -non -"non -" Patients with small cell lung cancer bring longer survival and significantly reduce the risk of brain metastases. Roche will, as always, adheres to the concept of "the first patient's needs", keeps advancing with the times, and introduce more innovative products to China faster to meet the unfinished needs of Chinese tumor patients. Patients who have made great contributions, medical professionals, and relevant government departments. "
Source: Yixu.com
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