FDA approved tagrisso as a first-line treatment for non-small cell lung cancer

Source: Wuxi apptec announced yesterday that its innovative anti lung cancer drug (osimertinib, oxitinib) was approved by the US FDA for the first-line treatment of patients with metastatic non-small cell lung cancer, and the tumor has EGFR mutation (exon 19 deletion or exon 21 L858R mutation) This is a great good news for the vast number of lung cancer patients We know that lung cancer is one of the most important causes of cancer death in the world, accounting for about 20% of cancer deaths in the world Every year, more people die from lung cancer than from breast cancer, prostate cancer and colorectal cancer! In lung cancer, non-small cell lung cancer is the most common type, accounting for 85% of the total number of lung cancer For Asian patients, their NSCLC often has EGFR mutations Although these patients can be controlled under the treatment of EGFR TKI (tyrosine kinase inhibitor), the tumor often produces resistance mutations such as EGFR T790M to the treatment, making the disease further progress These patients also need an effective new drug to save lives Tagrisso, brought by AstraZeneca, is one of the heavyweight new drugs emerging in recent years It is a kind of third generation, irreversible EGFR-TKI It can not only effectively target the general EGFR patients, but also the EGFR T790M resistant mutation patients In addition, it can also effectively target cancer metastasis in the central nervous system In a phase 3 clinical trial called flaura, the first-line antitumor effect of the new drug was verified In this clinical trial, the researchers recruited a group of patients with primary cancer who had advanced or metastatic non-small cell lung cancer with EGFR mutations These patients were divided into two groups, one group was treated with tagrisso, the other group was treated with EGFR TKI The results showed that the progression free survival time of patients in the control group was 10.2 months, while that in the tagrisso group was 18.9 months, significantly prolonged (P < 0.0001), which also reached the main clinical end point of the study Based on the excellent data of the trial, the US FDA also approved the new drug for the first-line treatment of non-small cell lung cancer indications ▲ relevant results of the flaura trial (photo source: Official Website of AstraZeneca) "the approval of oxitinib as a first-line therapy is a significant progress in the treatment of EGFR mutated tumor patients and an important change in the treatment paradigm," Suresh s Dr ramalingam said: "oshitinib has led to a significant improvement in progression free survival and no unexpected safety risks compared to other EGFR inhibitors." ▲ Mr Dave Fredrickson, global executive vice president and head of cancer Business Department of AstraZeneca (photo source: Official Website of AstraZeneca), "today's FDA approval of oshitinib as a first-line treatment drug is an exciting milestone for patients and our company," said Dave, global executive vice president and head of cancer Business Department of AstraZeneca Mr Fredrickson said: "oshitinib has shown unprecedented median progression free survival data in all pre-defined patient subgroups (including those with or without central nervous system metastasis), which can control tumor growth or spread and prolong the life of more patients." It is worth mentioning that tagrisso has been approved for listing in China under the trade name of Teresa As a partner over the years, we congratulate AstraZeneca on this important achievement and look forward to saving more patients' lives with this heavyweight drug!