美国食品和药物管理局批准尼拉巴里布组合治疗BRCA2突变前列腺癌,改善无进展生存率. FDA approves niraparib combo for BRCA2-mutated prostate cancer, improving progression-free survival.

根据AMPLITUDE试验,FDA已批准尼拉巴里布与阿比拉酸盐和普雷尼松联合用于转移性割敏感前列腺癌和BRCA2突变的成年人. The FDA has approved niraparib combined with abiraterone acetate and prednisone for adults with metastatic castration-sensitive prostate cancer and BRCA2 mutations, based on the AMPLITUDE trial. BRCA2突变的病人大大改善了放射学无进展性存活率,中位的RPFS没有达到,对照组为26个月。 Patients with BRCA2 mutations had significantly improved radiographic progression-free survival, with median rPFS not reached versus 26 months in the control group. 治疗减少了54%的疾病发展风险和延迟的症状发展。 The treatment reduced disease progression risk by 54% and delayed symptomatic progression. 在没有BRCA2变异的病人中,没有看到任何好处。 No benefit was seen in patients without BRCA2 mutations. 疗程带有严重副作用的警告,包括近距离抑制和肝毒性,建议只针对经证实BRCA2突变的人,通过经林业发展局批准的测试进行。 The regimen carries warnings for serious side effects, including myelosuppression and liver toxicity, and is recommended only for those with confirmed BRCA2 mutations via an FDA-approved test.