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    Home > Medical News > Medical Research Articles > Pfizer's oral PARP inhibitor TALZENNA ® has been approved by the European Commission

    Pfizer's oral PARP inhibitor TALZENNA ® has been approved by the European Commission

    • Last Update: 2020-06-09
    • Source: Internet
    • Author: User
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    recently, Pfizer announced that its oral PARP inhibitor TALZENNA ® (talazoparib) has been approved by the European Commission as a single drug to treat breast cancer susceptibility gene (gBRCA) 1/2 mutation, with human epidermal growth factor receptor 2 negative (HER2-) localized advanced or metastatic breast cancer patientson TalazoparibTalazoparib is a PARP inhibitor, and preclinical studies have shown that talazoparib causes cancer cell growth to decrease and cancer cells die by blocking parP enzyme activity and capturing PARP at the site of DNA damagethis approval is based on data from phase III clinical studies, which recruited 431 patients with gBRCA1/2 mutations and locallate or metastatic triple negative or HR/HER2-breast cancer, to assess the efficacy of 1 mg of talazoparib per day compared to standard chemotherapy (capecitabine, eribulin, gemciintabe or vinorelbine), with no progression (PFS)The results showed that the talazoparib group was significantly better than chemotherapy, extending the PFS median to 8.6 months, compared with 5.6 months in the standard chemotherapy groupSecondary endpoints of the(http://of the
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    of the include objective reaction rates (ORR), total lifetime (OS), and securityThe ORR in the Talazoparib group was 62.6% (95% CI: 55.8-69.0), more than twice the standard chemotherapy group (27.2%) (95% CI: 19.3-36.3)OS data is not yet matureIn terms of safety
    the most common adverse reactions in the Talazoparib group included fatigue (57.1%), anemia (49.6%), nausea (44.3%), neutropebutyl reduction (30.2%), thrombocyttosis (29.6%) and headache (26.5%)
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