China News Service, Beijing, March 25. The innovative drug Amberrium (Brigatinib) in the field of lung cancer has been approved by the National Medical Products Administration. The single drug is suitable for anaplastic lymphoma kinase (ALK)-positive local Treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC).
The drug is a new ALK tyrosine kinase inhibitor. Its efficacy in prolonging patient survival, controlling brain metastases, and improving quality of life has been clinically verified. It was included in the "CSCO Guidelines for the Diagnosis and Treatment of Non-Small Cell Lung Cancer".
The approval of this product will bring new treatment options to more Chinese lung cancer patients.
Lung cancer is one of the cancers with the highest morbidity and mortality worldwide.
In China, the morbidity and mortality of lung cancer ranks first among malignant tumors every year, which seriously threatens people's health.
Among them, ALK-positive advanced non-small cell lung cancer (ALK+mNSCLC) is a relatively rare and dangerous subtype, with nearly 35,000 new cases in China every year.
Such patients generally have a low mean age of onset and a high incidence of brain metastases.
Data show that 30% of patients with ALK-positive advanced non-small cell lung cancer have developed brain metastases at the time of initial diagnosis, and 75% of patients will develop brain progression within two years of treatment, seriously affecting survival and quality of life.
Therefore, the control and prevention of brain metastasis is the focus and difficulty of clinical treatment of ALK-positive advanced non-small cell lung cancer, and innovative and effective therapeutic drugs are urgently needed in clinical practice.
While improving the survival of patients, treatment is also very important for improving the quality of life of patients.
In addition, there is a huge unmet need for treatments targeting ALK fusion types and drug resistance mutations.
Professor Lu Shun, director of the Department of Oncology, Chest Hospital Affiliated to Shanghai Jiaotong University, said that although there are some treatment options for ALK-positive non-small cell carcinoma, the existing treatments for patients with ALK-positive non-small cell carcinoma have insufficient control of brain metastases. Drug resistance inevitably occurs during the process, and there are still unmet clinical needs.
The results of the ALTA-1L study showed that brigatinib has outstanding brain penetration properties, significant intracranial efficacy, and strong inhibitory effect on drug resistance sites.
"Both of these are very important to patients, so we are looking forward to this product."
Amberry (Brigatinib Tablets) mainly acts on ALK fusion mutations. Its unique dimethyl phosphine oxide (DMPO) structure strengthens the binding force with ALK protein, enhances drug activity, and also facilitates drug penetration through blood and brain. Barrier and maintaining brain blood concentration create favorable conditions, and at the same time can broadly inhibit multiple ALK fusion types and drug resistance mutations.
The drug significantly reduces the risk of disease progression or death in patients with ALK-positive advanced non-small cell lung cancer, prolongs progression-free survival (PFS), and achieves an overall survival benefit.
According to the results of the international multi-center phase III clinical study ALTA-1L, for patients treated with Amberry (brigatinib tablets), the median PFS assessed by the independent review committee reached 24 months, and the control group crizotinib The median PFS was 11.1 months (HR=0.48, P<0.0001), and the investigator-assessed median PFS was 30.8 months compared with 9.2 months in the control group (HR=0.43, P<0.0001), and Amberine (brigatinib) Tablets) reduced the risk of disease progression or death by 57% compared to the control group.
In addition, the drug's treatment data for brain metastases are very outstanding. The ALTA-1L results show that the confirmed objective response rate (ORR) for patients with baseline brain metastases was 78%, and the control group was 26%; The duration of remission was 27.9 months, compared with 9.2 months in the control group.
Amberry (brigatinib) extended baseline progression-free survival in patients with brain metastases, with a median PFS of 24 months as assessed by an independent review committee, compared with 5.6 months in the control group (HR=0.25, P<0.0001), compared with The control group had a 75% lower risk of disease progression or death.
The 4-year OS rate of Amberry (brigatinib tablets) first-line treatment for patients with brain metastases at baseline was 71%, and the risk of death was reduced by 57% (the 4-year OS rate in the control group was 44%, HR=0.43, P=0.02).
At the same time, the adverse reactions of Amberry (brigatinib tablets) are mostly mild, and the long-term use is safe and tolerable.
Based on the guarantee of efficacy and safety, the drug is the first ALK inhibitor that has been confirmed by clinical studies to have a significant difference in improving or maintaining the quality of life of patients compared with the control group.
Amberry (brigatinib tablets) is an innovative lung cancer drug under Takeda Pharmaceuticals. It has been approved in more than 40 countries and regions around the world, and has obtained FDA breakthrough therapy drug certification and orphan drug certification.
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