英文药名：Tagrisso Tablets（Osimertinib Mesilate）
AstraZeneca lung cancer drug Tagrisso approved by Japan
AstraZeneca, a British pharmaceutical giant, has also been approved by Japanese regulators for the new skin cancer drug testrisso (omisertinib, AZD9291), following the approval of the US and European markets in November and February last year. Cell growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) is used to treat resistant EGFR T790M mutations, surgery for incurable or recurrent non-small cell lung cancer (NSCLC).
It is estimated that about 30-40% of Asian NSCLC patients carry EGFR mutations at diagnosis, up to 2/3 of patients who have undergone the current treatment of EGFR-TKI have developed a T790M resistance mutation, treatment options are very limited. And Tagrisso will provide an important therapeutic option for such patients, which can simultaneously target EGFR mutations and T790M resistance mutations involved in tumorigenesis, which induces resistance to existing EGFR-TKI drugs.
AstraZeneca has teamed up to diagnose giant Roche has developed a cobaseGFR mutant companion diagnostic kit for accurate identification of patients who can benefit from the treatment of Tagrisso.
The approval was based on positive top-line data from two multinational AURA Phase II clinical trials (AURA Extended Study, AURA2 study), 22% of which were Japanese lung cancer patients. These studies demonstrate the efficacy and safety of Tagrisso in non-small cell lung cancer (NSLCL) and gene test to confirm EGFR T790M mutant-positive non-small cell lung cancer (NSCLC) during EGFR-TKI treatment or after treatment. In the AURA extended study (n = 199), the overall objective response rate (ORR, tumor shrinkage) reached 61.3% (95% CI: 54.2% -68.1%), the total objective response rate in the AURA2 study (n = 199) 70.9% (95% CI: 64.0% -77.1%) (as of May 1, 2015).
Tagrisso is the third generation of EGFR-TKI, designed to overcome the drug resistance to other drugs in the drug, including Roche / Astellas annual sales of 2 billion US dollars of erlotinib, AstraZeneca gefitinib, Boehringer Ingelheim. Tagrisso is the first drug to be marketed for T790M mutant-positive NSCLC for EGFR-TKI treatment or post-treatment progression.
Currently, AstraZeneca is conducting the AURA3 Phase III study, which involved EGFR T790M-positive locally advanced or metastatic NSCLC patients with progression after EGFR-TKI treatment, and compared Tagrisso with platinum-containing dual chemotherapy regimens. In addition, AstraZeneca is also investigating Tagrisso as adjuvant therapy and first-line therapy for metastatic NSCLC (including brain metastases), as well as combination therapy with Tagrisso and other drugs.
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