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Rubraca approved in U.S. as first PARP inhibitor approved for prostate cancer

 Last Update: 2020-05-29
 Source: Internet
 Author: User

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Clovis Oncology announced that the U.SFood and Drug Administration (FDA) has approved its oral PARP inhibitor Rubraca (rucaparib) tablets for adult patients with BRCA mutations in metastatic neurotic prostate cancer (mCRPC) who have been treated with androgen receptor target therapy and yewal chelate chemotherapyFDA approval for Rubraca's third indication is based on efficacy data from a multicenter single arm TRITON2 (NCT02952534) clinical trialThe main therapeutic results are the objective response rate (ORR) and reaction duration (DOR) assessed by Independent Radiology (IRR)The determined prostate-specific antigen (PSA) response rate is another pre-set endpointThe IRR assessment showed that the ORR was 44% in patients in the Rubreca treatment group, and the DOR range was 1.7-24 monthsIn 27 patients with an objective response, 15 (56%) had DOR for 6 monthsIn addition, 55% of prostate-specific antigens (PSA) response rates were observed in 115 patients with harmful BRCA mutationsThe most common level 3-4 adverse reactionis anemiaDrHoward Soule, Executive Vice President and Chief Scientific Officer,Prostate Cancer Foundation, said: 'Fda approval of Rubraca is an important milestone for patients with metastatic prostate cancer with harmful BRCA mutationsAlthough new treatments for prostate cancer have been approved in recent years, most men with the advanced disease still have little option'

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