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    Home > Active Ingredient News > Drugs Articles > AstraZeneca's $2 billion ovarian cancer drug lynparza has been approved by the European Union

    AstraZeneca's $2 billion ovarian cancer drug lynparza has been approved by the European Union

    • Last Update: 2014-12-19
    • Source: Internet
    • Author: User
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    Source: Biovalley, December 19, 2014 At the end of June this year, lynparza (olaparib), the anticancer drug of Azn, was rejected by the FDA Expert Committee Recently, the drug has gained great news in EU regulation The European Commission (EC) has approved lynparza as a single drug therapy for the maintenance treatment of platinum sensitive recurrent BRCA mutant ovarian cancer in adult patients The drug has also become the first PARP inhibitor for BRCA mutant platinum sensitive recurrent ovarian cancer 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's approval was based on data from a phase II clinical study (study 191) This study was carried out in patients with BRCA mutated ovarian cancer The data showed that olaparib significantly prolonged the progression free survival (PFS) compared with placebo (11.2 months vs 4.3 months, P < 0.00001) However, this data was criticized by the FDA Expert Committee in June this year FDA experts believe that olaparib did not improve the overall survival period (OS), and several worrying adverse events occurred in the study At the same time, they doubt the reliability of PFS data, so they refuse to accelerate the approval of olaparib, and require AstraZeneca to complete the ongoing III The FDA will make a review decision in January 2015 (related reading: AstraZeneca's "dead" anticancer drug olaparib "revived") AstraZeneca has high hopes for olaparib, and believes that the annual sales of the drug will exceed 2 billion US dollars However, AstraZeneca's expectation of anti-cancer immunotherapy PD-L1 inhibitor medi4736 and another anticancer drug azd9291 is higher, and 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 However, if these products want to achieve the expected goal, they will depend on the clinical success in a series of cancers 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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