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FDA approves Pfizer cancer drug Xalkori in the treatment of ROS1 positive non small cell lung cancer

Source:http://www.wisdomdrugs.com Tssuing time:2016-03-25

Research and development of the American pharmaceutical giant Pfizer (PFE) of oral targeted anticancer drug xalkori (crizotinib) in recent months in Europe and the United States regulatory news constantly. At the end of last year, first-line treatment of Xalkori positive anaplastic lymphoma kinase (ALK) in non-small cell lung cancer (NSCLC) approved by the European union. Just recently, Xalkori also won FDA approval for the treatment of ROS1 positive non-small cell lung cancer (NSCLC). Prior to this, Xalkori in the United States for anaplastic lymphoma kinase (ALK) in treatment of metastatic NSCLC positive.
The approval of Xalkori to become the first ROS1 positive NSCLC treatment in the field of targeted anticancer drugs driven by biomarkers, marking a major milestone in the type of lung cancer clinical treatment. Last year, FDA has awarded Xalkori treatment ROS1 positive NSCLC breakthrough drug eligibility, while giving priority to the review of eligibility.
ROS1 positive lung cancer: biological markers (ROS1 rearrangement) driven by precision medical and a classic example
The approval is based on a multi center single group phase I study (Study 1001) of the positive data. The study was carried out in 53 patients with metastatic non small cell lung cancer (NSCLC), which is actually a ROS1 rearrangement, and investigated the therapeutic potential of Xalkori. Study on patients with program standards of oral dose xalkori (250 mg, 2 times / day) treatment, assessment of drug safety, pharmacokinetics and response to therapy, and to identify ros1 fusion partner genes with the second generation sequencing and RT-PCR.
Data from 50 patients showed that the objective response rate (ORR) was 72% (95%CI:58-84%), 3 cases of complete remission, 33 cases of partial remission, the median duration of remission was 17.6 months, and the median progression free survival was 19.2 months. In the detected 30 cases of tumor specimens, the researchers found 7 ROS1 of the fusion partner: 5 known, 2 for the new discovery. No correlation was observed between the type of ROS1 rearrangement and the clinical response of NSCLC, and the safety of Xalkori was similar to that of ALK patients with Xalkori rearrangements. The complete data was published in the new England Journal of Medicine (NEJM) in November 20, 2014.
The study showed that Xalkori has significant anti-tumor effect on ROS1 rearrangement of advanced non small cell lung cancer (NSCLC). ROS1 rearrangement provides second effective treatments for Xalkori in patients with Ya Qun. Xalkori in the patient population in clinical development, is committed to the development of a biological marker (ROS1 rearrangement) identification of patients and then carry out a model of precision medicine.
About ROS1 gene rearrangement:
ROS1 rearrangement occurs in the ROS1 gene and another gene fusion and changes the normal function of the respective genes, which may drive the growth of cancer cells. Epidemiological data show that the incidence of ROS1 gene rearrangement in non small cell lung cancer (NSCLC) cases is about 1%. According to estimates, the global annual increase of 1 million 500 thousand NSCLC cases, of which about cases may be driven by the carcinogenic ROS1 gene rearrangement. ROS1 rearrangement defines a distinct molecular subtype of non small cell lung cancer (NSCLC), which may be sensitive to the treatment of ROS1 kinase inhibitors.
About Xalkori (crizotinib):
Xalkoi (crizotinib, zuoke imatinib) is a target to become lymphoma kinase (ALK), ros1 and met the small molecule tyrosine kinase inhibitor (TKI), in 2011 received FDA approval for ALK positive metastatic non small cell lung cancer (NSCLC) in patients with treatment. At present, Xalkori has been approved by more than 80 countries around the world, the drug is listed, has greatly changed the clinical treatment of ALK positive NSCLC.


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