FDA approves Pfizer's new cancer drug Talazoparib for treatment of breast cancer patients
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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breast cancer is one of the most important types of cancer that threaten a woman's lifeWomen who carry genetic BRCA1 or BRCA2 mutations have a 65 percent risk of developing breast cancer before age 70today, the U.SFDAannounced that it has approved Pfizer'scompany
(talazo) to treat patients with reproductive BRCA mutations (harmful or suspected harmful), HER2-negative localized advanced or metastatic breast cancerTalazoparib is a PARP inhibitor developed by PfizerThis is the 4th PARP inhibitor approved by the FDA to dateTalazoparibTalazoparib is an innovative PARP inhibitor developed by PfizerPreclinical studies have shown that talazoparib is powerful and has a dual mechanism to stimulate tumor cell death by blocking the activity of PARP enzymes and binding PARP enzymes to DNA damage sitesTalazoparib's new drug application is eligible for priority review by the FDAthis approval is based on an open label called REACH, Phase 3 ClinicalTrial(results) In the study, 431 patients were treated with a 2:1 ratio of talazoparib or a chemotherapy option chosen by their doctor All patients are required to carry a brca mutation in the reproductive line results showed a significant increase in progression-free survival (PFS) in patients receiving talazoparib compared to patients receiving chemotherapy, 8.6 months of PFS in the talazo group and 5.6 months in chemotherapy (HR 0.54, 95% CI: 0.41, 0.71; p 0.0001 This means that talazo reduced the risk of disease progression by 46% and the objective remission rate in the talazoparib group was 62.6%, more than double that of the chemotherapy group (27.0001) .
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