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    Home > Active Ingredient News > Drugs Articles > Christmas Day gift: AstraZeneca's ovarian cancer drug lynparza won two markets in Europe and the United States at the same time

    Christmas Day gift: AstraZeneca's ovarian cancer drug lynparza won two markets in Europe and the United States at the same time

    • Last Update: 2014-12-22
    • Source: Internet
    • Author: User
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    Source: Bio Valley December 21, 2014 / Bio Valley bio on / -- although it was rejected by the FDA expert committee, the FDA did not hesitate to accelerate the approval of AstraZeneca's ovarian cancer drug lynparza (olaparib) The approval of the drug also marks the addition of a heavyweight product to the AstraZeneca pipeline Just the day before, lynparza was also approved by the European Union (related reading: full blood resurrection: AstraZeneca's $2 billion ovarian cancer drug lynparza has been approved by the European Union) specifically, FDA has approved lynparza for the treatment of BRCA germline mutation advanced ovarian cancer patients who have failed at least three previous chemotherapy treatments Lynparza (olaparib) is the first oral poly ADP ribose polymerase (PARP) inhibitor It takes advantage of the defect of DNA repair pathway to kill cancer cells preferentially At present, AstraZeneca is carrying out a number of phase III studies to investigate the use of olaparib in the treatment of BRCA mutant ovarian cancer, gastric cancer and breast cancer Lynparza was approved by the FDA's accelerated approval process based on data from a single open label phase II study and safety data from other studies The phase II study was carried out in 137 patients with BrAC germline mutant advanced ovarian cancer who had failed at least three times of chemotherapy The data showed that olaparib maintenance therapy achieved a total response rate (ORR) of 34%, with a median response duration of 7.9 months A previous study showed that compared with placebo, olaparib significantly prolonged progression free survival (PFS: 11.2 months vs 4.3 months, P < 0.00001) In February this year, AstraZeneca submitted regulatory documents for olaparib to FDA based on phase II clinical data This study evaluated the treatment of platinum sensitive recurrent high serous ovarian cancer with olaparib In June, the FDA's Oncology Advisory Committee (ODAC) rejected the accelerated approval of olaparib by a vote of 11:2, and recommended that the FDA wait for the results of AstraZeneca's ongoing phase III clinical research In July, at the request of FDA, AstraZeneca submitted a major revision of olaparib's new drug application, providing additional data to support the use of olaparib in the treatment of BRCA germline mutant ovarian cancer patients who have failed at least three previous chemotherapy treatments At present, AstraZeneca is carrying out phase III solo clinical project FDA will conduct a comprehensive review on two phase III studies of the project, Solo-2 and solo-3, and then decide whether to transfer accelerated approval of olaparib to full approval The Solo-2 study is investigating the efficacy of olaparib as a maintenance therapy versus placebo; the solo-3 study is investigating the efficacy of olaparib versus standard chemotherapy in the treatment of recurrent ovarian cancer Data from the Solo-2 study is expected to be available in 2015 and data from the solo-3 study is expected to be available in 2019 Earlier this year, in rejecting Pfizer's $114 billion acquisition, AstraZeneca outlined to investors the bright future of its oncology pipeline AstraZeneca has high hopes for olaparib and believes that its annual sales will exceed 2 billion US dollars However, AstraZeneca has higher expectations for the tumor immunotherapy PD-L1 inhibitor medi4736 and another anticancer drug azd9291 The annual peak sales of the two drugs are predicted to be $6.5 billion and $3 billion, respectively The latter is currently in phase I clinical practice However, if these products want to achieve the expected goal, they will depend on the clinical success in a series of cancers In addition, in the field of ovarian cancer, FDA approved Avastin for recurrent ovarian cancer in November Amg-386, an ovarian cancer drug developed by Amgen, a biotechnology giant, is in phase III About BRCA gene: BRCA1 and BRCA2 genes are tumor suppressor coding genes Mutations of these genes are related to hereditary breast cancer and ovarian cancer If a woman inherits the BRCA1 or BRCA2 mutation, the risk of breast and / or ovarian cancer increases significantly Only 15% of ovarian cancer was found before cancer cells expanded beyond the ovary Although great progress has been made in treatment and diagnosis, cancer cells have spread to patients outside the ovary, and the 5-year survival rate is less than 50% About lynparza (olaparib): olaparib is an innovative and potential initiative oral poly ADP ribose polymerase (PARP) inhibitor It has been proved in preclinical models that it can take advantage of the defects of DNA repair pathway to preferentially kill cancer cells This mode of action gives olaparib the potential to treat a wide range of tumor types with DNA repair defects PARP is associated with a wide range of tumor types, especially breast and ovarian cancer.
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