AstraZeneca targeted drug Tagrisso for lung cancer approved in China

AstraZeneca targeted drug Tagrisso for lung cancer approved in China.  AstraZeneca’s targeted drug Tagrisso approved in China: adjuvant treatment of early-stage EGFR-mutant lung cancer!

AstraZeneca recently announced that the National Medical Products Administration (NMPA) of China has approved its targeted anticancer drug Tagrisso (Chinese trade name: Teresa, generic name: osimertinib, osimertinib): This kind of adjuvant (postoperative) therapy, and the doctor decides whether to use adjuvant chemotherapy, for the treatment of early stage (IB/II/IIIA) epidermal growth factor receptor mutations (EGFRm) that have undergone complete tumor resection for the purpose of cure Adult patients with non-small cell lung cancer (NSCLC).

Tagrisso is suitable for EGFRm NSCLC patients with EGFR exon 19 deletion or exon 21 (L858R) substitution mutation in the tumor. The indication was approved through the priority review process, and the “unprecedented” results from the ADAURA Phase 3 trial showed that Tagrisso adjuvant therapy reduced the risk of disease recurrence or death by 80%.

It is worth mentioning that Tagrisso is the only targeted drug that has shown efficacy in the treatment of early stage lung cancer in a global trial, and it is also the first such drug approved in China. The NMPA approval is based on the positive results of the global phase III registered clinical study ADAURA. Data show that in the main study population of stage II and stage IIIA EGFRm NSCLC patients, as well as in stage IB-IIIA patients with secondary endpoint indicators, Tagrisso showed statistically different and clinically significant disease-free survival (DFS). ) Benefit.

The specific data are:

(1) In stage II and IIIA patients, DFS results showed that Tagrisso reduced the risk of disease recurrence or death by 83% (HR=0.17; 99.06%CI: 0.11-0.26; p<0.001);

(2) In the overall study population of stage IB-IIIA patients, DFS results showed that Tagrisso reduced the risk of disease recurrence or death by 80% (HR=0.20; 99.12%CI: 0.14-0.30; p<0.001).

In all predetermined subgroups, including Asian and non-Asian patients, consistent DFS benefits were observed regardless of previous adjuvant chemotherapy. The safety and tolerability of Tagrisso in this study are consistent with previous studies in metastatic NSCLC. Related research results have been published in the “New England Journal of Medicine” (NEJM).

Lung cancer is a devastating disease. Although up to 30% of NSCLC patients may be diagnosed early enough to undergo radical surgery, recurrence of the disease is still common in early disease. According to previous data, nearly half of patients diagnosed in stage IB and more than three-quarters of patients diagnosed in stage IIIA will relapse within 5 years. More than one third of lung cancer patients in the world are in China. Among NSCLC patients, about 40% of patients have tumors with EGFR mutations.

Dave Fredrickson, Global Executive Vice President and Head of Oncology Division of AstraZeneca, said: “The rapid approval of Tagrisso in China as part of a curative treatment plan for early EGFR-mutant lung cancer highlights the significant unmet medical needs in this field. China It is one of the countries with the highest EGFR mutation rate. This approval also reflects our commitment to improving the prognosis of Chinese patients. This approval once again emphasizes the importance of EGFR testing for all lung cancer patients before treatment decisions to ensure As many patients as possible can benefit from targeted therapies such as Tagrisso, enabling patients to obtain longer cancer-free survival times.”

Tagrisso is an oral small molecule third representative EGFR-TKI inhibitor (EGFR-TKI), which has previously been approved by many countries around the world (including the United States, Japan, China, and the European Union):

(1) First-line treatment for patients with locally advanced or metastatic EGFRm NSCLC;

(2) Second-line treatment of locally advanced or metastatic NSCLC patients with positive EGFR T790M mutation.

In addition, Tagrisso is approved for the treatment of early stage lung cancer in more than ten countries including the United States.

This latest approval is the third indication that Tagrisso has been approved for the second-line treatment of EGFR T790M mutant NSCLC and the first-line treatment of EGFRm NSCLC in China. The first two indications have been included in the national medical insurance catalog.

Tagrisso is the third-generation irreversible EGFR-TKI with clinical activity against central nervous system metastasis. Globally, Tagrisso has treated approximately 250,000 patients.

Currently, AstraZeneca is developing Tagrisso for the treatment of EGFRm NSCLC patients with multiple disease stages, including: treatment of stage III locally advanced unresectable disease (LAURA study), neoadjuvant resectable disease (NeoADAURA), and combined chemotherapy for treatment of metastatic disease Disease (FLAURA2), combined with potential new drugs to solve the resistance to EGFR TKI (SAVANNAH study, ORCHARD study).

(source:internet, reference only)

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