European Commission approves Pfizer Talazoparib for treatment of adultbreast cancer
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Last Update: 2020-06-09
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Source: Internet
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Author: User
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European Commission (EC) has approved the targeted anti-cancer drug Talazoparib for the treatment of adult patients with 1/2 mutations in the type of breast cancer susceptibility gene (gBRCA), HER2-negative late-stage (LA) or metastatic breast cancer (MBC), the http://giant of the European Commission announcedTalzennaTalzenna is the only daily oral parp inhibitor approved for the treatment of hereditary breast cancer (HBC) in Europe, and the drug is the fourth PARP inhibitor approved worldwideIn the United States, the drug was approved by theFDA(http://in October 2018The other three approved PARP inhibitors are AstraZeneca Lynparza, Clovis(http://Rubraca, and Tesaro ,which has been acquired by GlaxoSmithKline, ZejulaTalzenna's approval is based on data from key, randomized Phase III clinical studies of Embracing AembracA (NCT01945775), the largest Phase III study to date in LA or MBC patients with gBRCA mutationsstudy in 145 clinicaltrials in 16 countries(http://in groups of 431 patients with gBRCA 1/2 mutations, three negatives or HR?/HER2-LA or MBC breast cancer, assessed the efficacy and safety of talazoparib compared to the doctor's choice of standard single-drug chemotherapy (initial chemotherapy (PCT): Capatabin, Ayzhblin, Gisitabin or Changchun in studies, patients were randomly assigned to receive talazoparib (1.0mg per day) or PCT at a 2:1 ratio All patients have known harmful or suspected harmful gBRCA mutations and have received no more than 3 cytotoxic chemotherapy regimens to treat late-local or metastatic diseases, while
a drug (http:// and/or yewe ethane has been treated in the treatment of new auxiliary, auxiliary, and/or metastatic diseases the main endpoint is the non-progressive survival (PFS) data assessed by the independent central evaluation of the blind law based on the physical tumor response evaluation standard RECIST 1.1, showing that the PFS of the talazoparib treatment group was significantly extended compared to the PCT treatment group (median PFS: 8.6 months vs 5.6 months, HR 0.54 (95% CI: 0.41-0.71), p 0.0001), disease progression risk significantly reduced by 46%, and the total mitigation rate doubled (ORR: 62.6% vs 27.2%, p 0.0001) In addition, pfASoparib treatment benefits were consistent across a pre-designated subgroup, including patients with a history of brain metastasis, patients who had previously undergone chemotherapy, TNBC patients, and HR-plus patients in the study, the incidence of level 3 and above in the talazoparib treatment group included anemia (35%), neutrophil reduction (17%), thrombocytle (17%) Talzenna was acquired by Pfizer for the acquisition of Medivation, an active drug ingredient called talazoparib, a polyADP-ribopolymerase (PARP) inhibitor preclinical studies have shown that talazoparib is highly effective and has a dual mechanism to induce tumor cell death by blocking the activity of PARP enzymes and capturing PARP at DNA damage sites Currently, talazoparib is being evaluated for use in gBRCAm breast cancer and other types of cancer for early TNBC and DNA damage repair (DDR) defects
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