A new breakthrough! Olapari is FDA approved to treat metastatic anti-aggressive prostate cancer with HRR gene mutation

2020 May 20, AstraZeneca and Merck today announced that Li Puzhuo ® (English trade name: Lynparza, common name: Ola Palley) has been approved in the United States for treatment homologous recombination repair (HRR) mutations in metastatic castration-resistant prostate cancer (mCRPC)US Food and Drug Administration (FDA) approved based on the results of this item Ola Palley PROfound Phase III clinical trials, relevant results was published this month in the "New England Journal of Medicine."Prostate cancer is the second most common cancer in men, although there is an increase in the number of treatments for mCRPC patients, but 5-year survival rate remains lowHRR gene mutations occur in approximately 20-30% of patients mCRPCOnePROfound clinical trial lead investigator, deputy director of Northwestern University's Robert · H · Lurie (RobertH.Lurie) MahaHussain Comprehensive Cancer Center, said: "In the era of precision medicine, diagnosis and treatment of prostate cancer has been behind other solid tumorsSo for Ola Palley approved, I am very excited, this will provide a molecularly targeted therapy .PROfound clinical trials of metastatic castration-resistant prostate cancer patients with mutations of the United States HRR is a globalI want to thank the study of patients involved in this study, their families, researchers and entire research team, "executive vice president of globalAstraZeneca, cause cancer, head DaveFredrickson said:." today, Ola Palley approved the first prostate cancer indicationsin PROfound test for male patients with BRCA mutations or ATM, and physician's choice of grace miscellaneous Lu amine or abiraterone compared Aura can Palley the median imaging study in patients with prolonged progression-free survival more than doubled, is the study confirmed PARP inhibitors only prolong overall survival in patientsthese results further demonstrate, by genomic test to determine a patient No mutations exist HRR for men with advanced prostate cancer diagnosis and treatment options is essentialDr"
Merck Research Laboratories, senior vice president and global head of Clinical Development and Chief Medical Officer RoyBaynes represents: '' based on phase III clinical trial data-resistant prostate cancer metastatic castration of male patients for the presence of mutations HRR, Ola paclitaxel PARP inhibitor as the only approved for this indicationThese approvals highlights the importance of genome detection of the disease to help determine male patient treatment programWe are very pleased to partner with AstraZeneca, further towards the overall goal of improving patient prognosis"The primary endpoint of the trial isimaging BRCA1 / 2 mutations or ATM (HRR gene mutations in a subgroup) progression-free survival (rPFS)The results show, Orapa Lee can reduce radiological progression or 66% risk of death (hazard ratio: 0.34; p-value <0.0001), with a median rPFS7.4 months, better than the 3.6 months grace miscellaneous Lu amine or abiraterone group />as key secondary endpoints of the study, the total population of the HRR gene mutation, Ola paclitaxel also significantly improved the patients RPFS, 51% reduction of radiological progression or risk of death (hazard ratio: 0.49; p value <0.0001)the median rPFS5.8 months, 3.5 months than En Lu heteroaryl or abiraterone amine groupsApril 24, 2020, updated research studies ProFound another key secondary endpoint - Ora paclitaxel in BRCA1 / 2 mutations or OS ATM data mCRPC patients, although the results show that more than 80% of the cross-patient group to Ola paclitaxel treatment group, but with the control group Well miscellaneous Lu amine or abiraterone compared Ola Palley still be able to significantly improve overall survival: 31% lower risk of death (hazard ratio: 0.69; p-value = 0.0175), Median OS extended to 19.0 months in the control group was 14.6 monthsOla paclitaxel approved indications in this prior treatment, after treatment by the progress of new endocrine drugs, or suspected harmful HRR gene or harmful germline mutation system mCRPC patientsOla Palley patients treated subject to the prior acceptance of FDA-approved companion diagnostic testscurrently, Aura is Palley EU and other jurisdictions receiving areas regulatory approval, for use in treating a patient mCRPC HRR gene mutationAstraZeneca and other tests being carried out using Merck Ola paclitaxel treatment of metastatic prostate cancer, including the ongoing PROpel phase III clinical trialthis trial designed to assess joint Ola paclitaxel efficacy compared to the use of abiraterone acetate abiraterone acetate in patients mCRPC line separately* referred to herein adaptation disease is still in the development stage in China has not yet approved AstraZeneca does not recommend any use of unapproved drugsreferenceliterature 1.Brayetal (2018) .Globalcancerstatistics2018...: GLOBOCANestimatesofincidenceandmortalityworldwidefor362.Cancer.Net cancersin185countries.CA:ACancerJournalforClinicians,68(6),pp.394-424 (2019) .Treatmentofmetastaticcastration-resistantprostatecancer. / research-and-advocacy / asco-care -and-treatment-recommendations-patients / treatment-metastatic-castration-resistant-prostate-cancer [Accessed: November2019] 3.Kirby, M., 2011.Characterisingthecastration-resistantprostatecancerpopulation: asystematicreview.InternationalJournalofClinicalPractice, 65 (11 ), pp.1180-1192 4.Mateo, J, etal (2015) .DNA-repairdefectsandolaparibinmetastaticprostatecancer.NewEnglandJournalofMedicine, 373 (18), 5.Lietal pp.1697-1708 (2008 ) .HomologousrecombinationinDNArepairandDNAdamagetolerance.CellResearch, 18 (1), 6.Ledermannetal pp.99-113 (2016) .Homologousrecombinationdeficiencyandovariancancer.EuropeanJournalofCancer, 60, pp.49-58 < br />